Imported embolization coil classification: "artificial body part" vs implanted therapeutic appliance; placed under CTI 9021 90 90.

The dominant issue was classification of an imported embolization coil under Heading 9021, i.e., as an "artificial part of the body" (CTI 9021 39 00) or as an "other appliance, implanted in the body, to compensate for a defect or disability" (CTI 9021 90 90). Applying the tariff language, legal notes, and interpretative principles, the AAR held the coil achieves therapeutic effect by controlled occlusion within an existing vessel and does not replace or anatomically substitute a defective body part, so it falls outside the single-dash entries covering artificial parts. Foreign rulings were found non-persuasive due to divergence at the eight-digit level and dissimilar device function. The coil was classified under CTI 9021 90 90.

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1. ISSUES PRESENTED AND CONSIDERED

(i) Whether the imported "embolization coil" is classifiable as an "other artificial part of the body" under tariff item 9021 39 00, or as an "other appliance ... implanted in the body, to compensate for a defect or disability" under tariff item 9021 90 90.

2. ISSUE-WISE DETAILED ANALYSIS

Issue (i): Classification between tariff items 9021 39 00 and 9021 90 90

Legal framework (as discussed by the Court): The Court applied the General Rules for Interpretation, primarily Rule 1 (classification by terms of headings and relative notes) and considered the scope of Heading 9021 and its competing "other" sub-categories, read with the explanatory material reproduced and relied upon in the reasoning to distinguish (a) "artificial parts of the body" that replace defective parts, from (b) other wearable/carried/implantable appliances compensating a defect or disability.

Interpretation and reasoning: The Court found that Heading 9021 covers the product at the four-digit level as an implanted device intended to compensate for a defect. The determinative question was whether it qualifies as an "artificial part of the body" under 9021 39 00. On the facts, the embolization coil is implanted into an existing blood vessel/aneurysmal cavity to induce controlled thrombosis and achieve occlusion; it does not replicate, replace, or substitute the anatomical structure of a vessel or aneurysm wall segment. The Court treated anatomical replacement/substitution as a necessary condition for 9021 39 00, and held that while "resemblance" may not be an absolute test, the requirement of substitution/replacement of anatomy is non-negotiable for classification as an artificial body part. The coil's therapeutic mechanism-deliberate intravascular occlusion while the native vessel continues to exist-fails that replacement test. The Court further reasoned that, by elimination, once 9021 31/39 is inapplicable, the appropriate residual classification is 9021 90 90, which covers implanted appliances compensating a defect or disability but not replacing anatomy.

Conclusions: The Court rejected classification under 9021 39 00 and conclusively held that the embolization coil is classifiable under Heading 9021, specifically tariff item 9021 90 90, as an implanted appliance compensating for a defect/disability without anatomical substitution.

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