TaxTMI 
TaxTMI 
2026 (1) TMI 863
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.... Private Limited (hereinafter referred to as "the Applicant", "the Company", "Medtronic", "we", "our", or "us"), having our office at 4th Floor, SAS Tower, Sector 38, Medanta Hospital, Gurugram, Haryana - 122001, holding IEC number 3496003171, are engaged in the trading and distribution of medical devices and technologies, providing solutions in areas such as heart care, surgery, brain and spine conditions, and diabetes management. 1.3. As part of its operations in India, the applicant imports Onyx Embolization System (hereinafter referred to as "onyx" or "Onyx Embolic Liquid" or "the product", "the product under consideration", or "the product in question") for use in medical and surgical procedures. The Onyx Embolization System is a liquid, non-adhesive embolic agent used in neurovascular and peripheral vascular procedures. It is a pre-mixed, radiopaque solution composed of ethylene vinyl-alcohol copolymer (EVOH), dimethyl sulfoxide (DMSO), and micronized tantalum powder. It is primarily used for the treatment of brain arteriovenous malformations (AVMs) and other vascular abnormalities. It is delivered through a microcatheter in a liquid form and solidifies on contact with blo....
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....onnections in the brain, reducing rupture and haemorrhage risk. * Dural arteriovenous fistulas (DAVFs): Seals abnormal vascular channels in the dura mater, alleviating neurological symptoms and preventing intracranial bleeding. * Hypervascular tumors: Reduces blood supply to tumors (e.g., meningiomas) prior to surgical resection, minimizing intraoperative bleeding. * Peripheral vascular malformations: Used for embolization in selected cases outside the brain (e.g., in limbs or trunk), including arteriovenous malformations, bleeding, tumors, and endoleaks. This helps occlude complex vascular networks, decrease abnormal blood flow, relieve symptoms (pain, swelling), and facilitate surgical excision or improve cosmetic/functional outcome. 1.7. Implantation procedure of Onyx Embolic Liquid The implantation of Onyx embolic liquid follows a structured endovascular approach consisting of the following key steps: * Catheterization ⮚ Under fluoroscopic guidance, a DMSO compatible microcatheter is carefully navigated through the vascular system to the target vessel or AVM nidus. ⮚ Achieving a precise and stable positio....
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....are worn or carried, or implanted in the body, to compensate for a defect or disability. 1.9.2. At the outset, we have analysed tariff heading 3004 (medicaments) and understand that it is inapplicable to the Onyx Liquid Embolic System. Heading 3004 covers "medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale," such as tablets, ampoules, capsules, drops, or pastilles, which act through pharmacological, immunological, or metabolic processes after being absorbed into the body. The Onyx System, by contrast, is not presented or administered as a medicinal preparation but is supplied and used as an implantable interventional device: it is delivered through a microcatheter and solidifies in situ to form a polymer cast that mechanically occludes abnormal vessels. The constituent materials ethylene-vinyl alcohol copolymer, dimethyl sulfoxide (used here solely as a solvent), and tantalum are not considered active pharmaceutical ingredients, but rather device or excipient-type components that are not intended to produce systemic therapeutic effects. For these reasons, presentation, intende....
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....ant for stroke treatment, unrelated to Orthopedic use. 9021 21/ 9021 29 Artificial teeth and dental fittings Applies exclusively to dental prosthetics. The device has no application in dentistry or oral health. 9021 31/ 9021 39 Other artificial parts of the body 9021.39 is potentially applicable. The product is an artificial, implantable device designed to be used in neurovascular and peripheral interventions. It is introduced in the vascular cavity using Catheter system, when the liquid enters in the blood stream it solidifies at the treatment site, forming a spongy mass that functions akin to a body part, thereby physically occluding abnormal vessels. 9021 40 Hearing aids, excluding parts and accessories Specific to hearing assistance devices. No relevance to thrombectomy or vascular restoration. 9021 50 Pacemakers stimulating heart muscles, excluding parts and accessories for Pertains to electrical cardiac devices. The product is a mechanical device for clot / aneurysm / aneurysm removal, not an electrical stimulator. 9021 90 Other 9021 90- Another relevant subheading if the product does not fall in any of the above subheadings 1.9....
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....f entries. This includes a comparative analysis of the scope, legal notes, and explanatory guidance associated with each heading, in accordance with the General Rules of Interpretation (GRI) of the Harmonized System of Nomenclature and applicable provisions under the Indian Customs Tariff Act. The objective is to place before your Authority a legally sound and internationally consistent classification for the product. 1.9.9. It is pertinent to note that the applicable rate of customs duty for both competing tariff entries remains the same. Consequently, the issue of classification in this case is revenue neutral and does not impact the overall duty liability. Tariff entry 9021 90 90 9021 39 00 Heading Description Others Other artificial parts of the body --- Other BCD 7.5% 7.5% 1.9.10. In light of the above, the Applicant has respectfully approached the Authority for ruling on the question of appropriate classification of the Onyx Embolic Liquid System. Statement containing the Applicant's interpretation of law and facts in respect of the aforesaid question(s) 1.10. General Rules of Interpretation The classifi....
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....r and subchapter notes also apply, unless the context otherwise requires." 1.11. Classification of the product under consideration under CTH 9021. 1.11.1. Chapter 90 of the First Schedule to the Indian Customs Tariff Act encompasses a broad spectrum of instruments and apparatus used in scientific, medical, optical, and technical domains. These include optical instruments (e.g., lenses, prisms, microscopes), photographic and cinematographic equipment (e.g., cameras, projectors), measuring and checking instruments (e.g., thermometers, pressure gauges), precision tools, and medical or surgical devices (e.g., syringes. diagnostic instruments). The Chapter also covers parts and accessories associated with these instruments: Chapter 90 Optical, photographic, cinematographic, measuring checking, precision, medical or surgical instruments and apparatus, parts and accessories thereof. 1.11.2. The relevant heading under consideration, CTH 9021, specifically covers Orthopaedic appliances and medical devices intended to compensate for physical disabilities or defects, whether congenital or acquired. It also encompasses artificial parts of the body such as limbs and joints,....
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....Organization (WCO) Explanatory Notes to Heading 9021 clarify that subheading 9021.39 pertains to "other artificial parts of the body." This subheading is not limited to devices that physically replace missing anatomy, but also includes implantable devices that compensate for or correct defective anatomical structures by assuming or supporting their function. Examples include vascular stents, which keep narrowed arteries open, and embolization coils, which permanently occlude aneurysmal sacs to prevent rupture. 1.15. In addition, Section III(C) of the Explanatory Notes to heading 9021 explicitly lists examples such as artificial limbs, joints, and synthetic fiber tubes for replacing blood vessels and heart valves, highlighting the inclusion of implantable devices. 1.16. Relevant extract from the explanatory notes is reproduced below for reference: EN 9021(III)(C) covers: (III) Artificial Limbs, Eyes, Teeth and Other Artificial Parts of The Body These wholly or partially replace defective parts of the body and usually resemble them in appearance. (C) Other artificial parts of the body, e.g., arms, forearms, hands, legs, feet, noses, artificia....
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....externally worn (e.g., prosthetic limbs, eyes). Generally worn, carried, or implanted electronic aids; also includes non- implantable parts/accessories (e.g., connectors, valves). Function Specificity Mimic, replace, or structurally compensate for the form or function of the body part. Support body function or mitigate disability without being a direct anatomical replacement. Medical Use Cardiovascular, orthopaedic, reconstructive, and dental applications. Assistive or therapeutic aids (speech, vision, insulin delivery), and components/parts for prosthetic devices. Examples Artificial limbs, eyes, teeth; artificial heart valves; vascular stents; embolization coils (e.g., Axium ^TM); orthopaedic implants. Speech aids, electronic aids for the blind, insulin pumps; connectors, valves, fittings for prosthetic/implant devices. Customs Classification Focused on functional or structural anatomical replacement/support devices. Based on residual coverage: parts, accessories, or standalone aids compensating disability but not artificial body parts. 1.19. As discussed, the Onyx Embolic Liquid System is an implantable medical device specifically design....
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....fication under residual sub- heading 9021.90 would be inappropriate. 1.23. The distinction between anatomical and physiological aspects is critical in HSN classification of medical devices. Anatomical relates to physical structures of the body (bones, tissues, organs), and devices that replace or restore such structures (e.g., spinal implants, artificial heart valves, embolization coils, stents) are considered anatomical whereas Physiological refers to body functions or processes (e.g., circulation, respiration, endocrine activity), and devices that assist or regulate these (e.g., ventilators, insulin pumps) are considered physiological. The Onyx Embolic Liquid System is anatomical in nature, as it restores the structural integrity of blood vessels, unlike devices like insulin pumps, that merely regulate or compensate for functions. 1.24. Accordingly, the Onyx Embolic Liquid System meets the criteria for classification under HS Code 9021.39, which covers "other artificial parts of the body." This classification is justified by both its functional role and design characteristics. The device achieves durable occlusion of abnormal blood vessels, thereby restoring and supporting ....
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....der Customs Tariff Heading (CTH) 9021.39.00, based on the following grounds: ⮚ The Onyx Liquid Embolic System (LESTM) is a non-adhesive liquid embolic agent used for the embolization of neurovascular and peripheral vascular lesions. Onyx shares the same therapeutic goal as embolization coils, aiming to occlude abnormal blood vessels and is indicated for the treatment of aneurysms, arteriovenous malformations (AVMs), fistulas, and tumors. Once deployed, it solidifies at the target site, acting as a permanent implant that induces thrombosis and ensures long-term vessel closure. ⮚ In accordance with General Rules of Interpretation (GRI) 1 and 6, classification must be determined by the terms of the headings and relevant Section or Chapter Notes. Heading 9021 covers medical or surgical instruments and devices; therefore, the Onyx Embolic Liquid is covered under Heading 9021. ⮚ The World Customs Organization (WCO) Explanatory Notes to Heading 9021, particularly Section III(C), explicitly include implantable medical devices under subheading 9021.39 as "other artificial parts of the body," including "tubes of synthetic fabric for replacing b....
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....terms of c(i). 2.3. As per the available records, the specific matter is not pending in any appellate tribunal or Court. 2.4. The Importer has started importing the said goods vide BE No. 2783799 dated 20.06.2025 has imported the goods namely "00847536028678 ONYX LIQUID EMBOLIC SYSTEM 105-7315- 080" under CTI 90219090, hence the activity is ongoing in INMAA4. 2.5. Comments on the merits of the question raised in the application, along with all materials in support thereof. CLASSIFICATION ANALYSIS - ONYX EMBOLIZATION SYSTEM: 2.6. THE PRODUCT - ONYX EMBOLIZATION SYSTEM i. The importer vide application for advance ruling has submitted the following regarding the product: ii. Onyx Embolization system is a non-adhesive liquid embolic agent used for the embolization of neurovascular and peripheral vascular lesions. It is composed of biocompatible solutions: a. Ethylene Vinyl Alcohol (EVOH) Copolymer - This is the main material that acts as the blocker. When injected, it turns solid inside the blood vessel and blocks it. b. Dimethyl Sulfoxide (DMSO) - This is a liquid carrier that keeps EVOH in a flowable (liquid) form until it's inje....
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....00 - OTHER ARTIFICIAL PARTS OF THE BODY i. Sub-heading 9021 39 00 covers "Other artificial parts of the body" - a residual category for artificial body parts that are not joints (9021 31 00), teeth (9021 21 00), or other specifically enumerated items. ii. The Chapter notes have no definition of "other artificial parts of the body" however the WCO Harmonized System Explanatory Notes describe it as below: (III) ARTIFICIAL LIMBS, EYES, TEETH AND OTHER ARTIFICIAL PARTS OF THE BODY These wholly or partially replace defective parts of the body and usually resemble them in appearance. They include: (C) Other artificial parts of the body, e.g., arms, forearms, hands, legs, feet, noses, artificial joints (e.g., for hips, knees), and tubes of synthetic fabric for replacing blood vessels and heart-valves. "(III) ARTIFICIAL LIMBS, EYES, TEETH AND OTHER ARTIFICIAL PARTS OF THE BODY These wholly or partially replace defective parts of the body and usually resemble them in appearance. They include: (A) Artificial ocular fittings: (1) Artificial eyes. These are usually made of plastics or glass to which small quantities of metall....
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....eet, noses, artificial joints (e.g.,. for hips, knees), and tubes of synthetic fabric for replacing blood vessels and heart-valves. The heading excludes pieces of bone or skin for grafting, in sterile containers (heading 30.01) and bone reconstruction cements (heading: (heading 30.06) iii. This sub-heading covers devices that wholly or partially replace defective parts of the body and usually resemble them in appearance. The defining characteristic is replacement of existing body parts or structures. The examples illustrated in para (C) of the Explanatory Notes are also on those lines that is, existing parts of body or structure such as arms, forearms, hands, legs, feet, noses etc. iv. Applicability to Onyx Embolization System a. The Onyx Embolization System does not satisfy the criteria for classification under 9021 39 00 for the following reasons: b. Does Not Replace Any Body Part: The Onyx system is deployed within existing abnormal blood vessels and it does not replace an absent, defective, or removed body part. The blood vessels into which it is deployed continue to exist anatomically: the Onyx system fills and occludes these abnorm....
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....b. The Onyx system is an appliance "implanted in the body, to compensate for a defect or disability" and it is implanted to treat abnormal vascular malformations (cerebral arteriovenous malformations, dural arteriovenous fistulas, hypervascular tumors, and peripheral vascular malformations) by permanently occluding abnormal blood vessels and preventing haemorrhage, rupture, or neurological complications, which are bodily defects or medical conditions requiring intervention. c. Not an Artificial Body Part: As established above, the Onyx system does not replace any body part and therefore cannot be classified under sub-headings 9021 31 to 9021 39. d. Falls Under "Other": By elimination, the Onyx system falls under CTH 9021 90 - "Other." Since it is not a part or accessory of a hearing aid (9021 90 10), it is classified under CTI 9021 90 90. 2.9. APPLICATION OF GENERAL RULES FOR INTERPRETATION 2.9.1. GIR Rule 1: Classification is determined according to the terms of the headings and Section/Chapter Notes a. Heading 9021 covers: "Orthopaedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial par....
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....e most specific description shall be preferred a. Rule 3(a) is not applicable here because the Onyx Embolization System does not satisfy the essential characteristics of CTI 9021 39 00. The issue is not choosing between two equally applicable descriptions and rather, only one description (9021 90 90) applies because the Onyx system fails the definitional test for artificial body parts. b. The Explanatory Notes explicitly states that artificial parts must "wholly or partially replace defective parts of the body." The Onyx Embolization System does not replace, and it occludes and blocks abnormal vessels from within. This is a qualitative difference, not a matter of specificity. 2.9.4. CONCLUSION UNDER GENERAL RULES FOR INTERPRETATION a. Application of GIR Rules 1 and 6 leads unambiguously to classification under CTI 9021 90 90. b. The Onyx Embolization System falls within heading 9021 (Rule 1) as an implanted medical appliance. Within the subheadings, it does not qualify as an artificial body part (9021 39 00) because it does not replace any body structure - it permanently occludes and blocks abnormal blood vessels from within by forming a polym....
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....lance" is determinative - these criteria distinguish true artificial body parts (9021 31-39) from other medical implants and therapeutic devices (9021 90 90). 2.11. As per the available records, the specific matter regarding the classification of the Onyx Embolization System is not pending in any appellate tribunal or court. 3. Record of Personal hearing: Personal hearing in the matter was conducted through virtual mode on 12.12.2025, wherein the authorized representatives of the applicant attended the same and reiterated the facts which were already submitted in the application. No one attended the PH on behalf of the Department. 4. Additional Submission of the Applicant: 4.1. It is submitted that the applicant proposed the following competing tariff entries for classification of the impugned product: Competing entry 1 Competing entry 2 Tariff entry 9021 39 00 9021 90 90 Heading Description Other artificial parts of the body Others 4.2. The applicant had proposed classification of the product under sub-heading 9021 39 00 on the grounds that the product meets the essential characteristics of an artificial part of the body inten....
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....cluding abnormal vascular channels and stopping blood flow, not by replacing the defective structure with an artificial equivalent. 4.4.4. Doesn't replace any blood vessel: The Explanatory Notes specifically mention "tubes of synthetic fabric for replacing blood vessels" - these are prosthetic vessels that replace damaged or diseased blood vessel segments. In contrast, the ONYX EMBOLIZATION SYSTEM does not replace the blood vessel; it occludes and blocks existing abnormal vessels from the inside by forming a permanent polymer cast within them. 4.5. Before we proceed to provide our submission in respect of classification under 9021 39, it is important to understand the coverage of products under 9021 39 vis-à-vis 9021 90. In terms of explanatory notes (EN), 9021 39 covers "other artificial parts of the body." Relevant extract of EN reproduced below for reference: EN 9021(III)(C) covers: (III) Artificial Limbs, Eyes, Teeth and Other Artificial Parts of The Body These wholly or partially replace defective parts of the body and usually resemble them in appearance. (A) ... (B) ... (C) Other artificial parts of the bo....
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....sidual subheading. Covers (i) certain standalone compensatory appliances (mainly electronic aids) and (ii) parts and accessories of devices under 9021; Function Devices that replace, support, or assume the role of a natural body part. Devices that help compensate for a defect or disability, or parts that enable/assist 9021 devices, but are not themselves artificial body parts. Standalone Use Yes, typically standalone prosthetic or implantable devices with independent therapeutic/anatomical function. Yes, may include standalone assistive appliances (e.g., electronic aids) or accessories/parts for 9021 devices. Implantability/Wearability Often permanently implanted (e.g., heart valves, stents, ONYX EMBOLIZATION SYSTEMs) or externally worn (e.g., prosthetic limbs, eyes). Generally worn, carried, or implanted electronic aids; also includes non- implantable parts/accessories (e.g., connectors, valves). Function Specificity Mimic, replace, or structurally compensate for the form or function of the body part. Support body function or mitigate disability without being a direct anatomical replacement. Medical Use Cardiovascular, or....
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....ascular system. The evolution from fabric grafts to stents. embolisation coils, and ONYX embolisation systems represents a technological advancement rather than a change in functional purpose. Therefore, these modern endovascular devices should be considered as "artificial parts of the body" and continue to be classified under sub-heading 9021.39. 4.10. Additionally, it is important to note that when the Explanatory Notes do not explicitly cover newer medical technologies, classification should be determined by referring to comparable items that existed at the time the Notes were drafted. Reliance may also be placed on US CBP Ruling E89824, which specifically pertains to an embolic liquid and contains a similar observation. The relevant extract is reproduced below for reference: EN III to HS 90.21 does state that they "wholly or partially replace defective parts of the body ..." Normally an embolism is avoided whenever possible, instead of being produced artificially, as here. However, we believe the EN language has to be interpreted noting that this item did not exist at the time the EN was written. It was true at the time of its writing that the only artificial body p....
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....nder Heading 9021, such as connectors, valves, or mechanical fittings, and (ii) certain standalone appliances that compensate for a defect or disability but are not artificial body parts in themselves. The latter group primarily covers electronic or assistive devices, for example speech aids, electronic aids for the blind, or insulin pumps, which support or compensate for a disability without being a structural replacement of anatomy. Accordingly, classification under 9021.90 is appropriate only where the item is either a part/accessory intended solely or principally for use with a 9021 device, or a compensatory appliance of the type described in the Explanatory Notes. 4.15. In contrast, The ONYX LIQUID EMBOLIC SYSTEM is neither an accessory nor an external assistive device. It is an implantable, biocompatible prosthetic device that performs a therapeutic structural function within the human body. Once delivered into the vascular system, it creates a permanent occlusion or stabilization of abnormal blood vessels, thereby correcting or compensating for vascular defects. By performing this direct anatomical restoration, the device falls squarely within the definition o....
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....preventing rupture, or redirecting abnormal blood flow. Both types of devices address the same clinical objective of correcting or compensating for vascular defects. Its implantable, biocompatible, and prosthetic nature fully aligns it with the intent of subheading 9021.39. 4.18.5. Prosthetic definition includes functional compensation: "Artificial parts of the body" extends beyond physical replacement to devices that compensate for functional defects. Modern biomedical practice recognizes stents, embolisation coils, and ONYX LIQUID EMBOLIC SYSTEMs as prosthetic devices that restore structural and functional integrity. Accordingly, the ONYX LIQUID EMBOLIC SYSTEM qualifies under subheading 9021.39. 4.18.6. Therapeutic restoration, not Pathological Obstruction: The ONYX LIQUID EMBOLIC SYSTEM restores vascular integrity by creating controlled occlusions to stabilize aneurysms, stop bleeding, or manage arteriovenous malformations. Its action is corrective and stabilizing, designed to address physiological defects, consistent with other implantable prosthetic devices under CTH 9021. 4.18.7. Explanatory Notes have provided examples, not prescribed limitation: The Explanatory Not....
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....lities by delivering through a microcatheter in a liquid form and solidifies on contact with blood, forming a spongy polymer cast that block abnormal blood flow. Further, the applicant has submitted that the product performs the function of embolization as it block abnormal blood vessels in the brain or other parts of the body; once deployed, it acts as permanent implants that promote thrombosis and ensure long-term vessel closure. Under fluoroscopic guidance, a microcatheter is navigated through the vascular system to reach the site of the abnormal vascular lesion. Once in place, the Onyx liquid embolic agent is slowly injected through the microcatheter into the abnormal blood vessels. Upon contact with blood, the DMSO carrier diffuses away, causing the EVOH copolymer to precipitate and solidify, forming a spongy polymer cast that fills and occludes the abnormal vascular channels. Further, the applicant in his application contended that the impugned goods merit classification under CTI 902 1 39 00, which is meant for 'artificial part of body". 5.2.1 I note that the jurisdictional Commissionerate in its comments has observed that the Onyx Embolization system, though an impla....
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....rts and accessories 9021 90 - Other: 9021 90 10 --- Parts and accessories of hearing aids 9021 90 90 --- Other 5.3.1 The relevant explanatory notes of Tariff Heading 9021 are reproduced below :- "(III) ARTIFICIAL LIMBS, EYES, TEETH AND OTHER ARTIFICIAL PARTS OF THE BODY These wholly or partially replace defective parts of the body and usually resemble them in appearance. They include: (A) Artificial ocular fittings: (1) Artificial eyes. These are usually made of plastics or glass to which small quantities of metallic oxides have been added in order to imitate the features and colouring of the various parts of the human eye (sclera, iris, pupil). They may be of single or of double shell types. (2) Intra-ocular lenses. Artificial eyes for tailors dummies, for furs, etc., are excluded (generally classified heading 39.26 or 70.18); artificial eyes identifiable as parts of dolls or of toy animals fall in heading 95.03 or in heading 70.18, if they are of glass (B) Artificial teeth and dental fittings, for example: (1) Solid artificial teeth, usually made of porcelain or plastics (acrylic polym....
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....ed to appliances for overcoming deafness; it therefore excludes articles such as headphones, amplifiers and the like used in conference rooms or hy telephonists to improve the audibility of speech. (V) OTHER APPLIANCES WHICH ARE WORN OR CARRIED, OR IMPLANTED IN THE BODY, TO COMPENSATE FOR A DEFECT OR DISABILITY This group includes: (1) Speech-aids for persons having lost the use of their vocal cords as a result of an injury or a surgical operation. These consist essentially of an electronic impulse generator: When pressed against the neck, for example, they generate vibrations in the cavities of the throat which are modulated by the user to produce audible speech. (2) Pacemakers for stimulating defective heart muscles. These are roughly the size and weight of a pocket watch and are implanted beneath the skin of the patient's chest. They incorporate an electric battery and are connected by electrodes to the heart, which they provide with the impulses necessary for its functioning. Other types of pacemakers are used to stimulate other organs (for example, the lungs, the rectum or the bladder). (3) Electronic aids for the blind. These consist....
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....ate for physiological deficiencies, such as pacemakers, speech aids for persons without vocal cords, and electronic aids for the blind. 5.3.4 On examination of the product under consideration viz. "Onyx Embolization system", I observe that the fundamental purpose of the Onyx system is to occlude and block abnormal blood vessels by stopping blood flow from within the vascular structure. This is different from replacing or restoring normal anatomical structure of the vessels. The system blocks an existing abnormal vessel rather than substituting for a missing or removed structure implanted within an existing blood vessel. Its function is therefore therapeutic rather than structural replacement. The device is a self-contained implantable medical appliance and is not intended to act as an artificial part of the body in the sense contemplated under CTI 9021 31 00 or 9021 39 00. 5.3.5 I observe that the applicant has argued that "usually resemble them in appearance" is descriptive and should not be limiting, providing examples of stents and coils as modern equivalents. In this regard, I note that while resemblance is not an absolute test, substitution or replacement of anatomy is a....
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....ind; (iv) Appliances implanted to support or replace chemical/physiological function of organs (like insulin pumps); and (v) Parts and accessories of 9021 devices. 5.3.10 I find that this class forms a group of implantable or wearable medical appliances that compensate defects or disabilities, but do not replace anatomy and are not parts or accessories of other 9021 devices unless imported as such. I observe that Onyx embolization system is a standalone, self-contained implantable medical appliance which is implanted in the body to compensate for a defect or disability and to treat vascular malformations by permanently occluding abnormal blood vessels and preventing haemorrhage, rupture and neurological complications. 5.3.11 Thus, I find that the product satisfies the legal scope of CTI 9021 90 90 as it is implanted in the body and compensates medical defects (AVMs, DAVFs, Hypervascular Tumors, Peripheral Vascular Malformations) but it does not replace anatomy and the same is not covered by preceding single-dash entries CTI 9021 10 to 39. 5.3.12 I have considered the U.S. CBP rulings i.e. NY E89824, NY N040455 cited by the applicant in their support. Thes....