The tariff classification of Coronary Stents

NY R01605 March 18, 2005 CLA-2-90:RR:NC:N1:105 R01605 CATEGORY: Classification TARIFF NO.: 9021.39.0000 Mr. Jim Darrell Hendricks Guidant Corporation, VI 26531 Ynez Road Temecula, CA 92591 RE: The tariff classification of Coronary Stents Dear Mr. Hendricks: In your submission dated March 11, 2005, you requested a tariff classification ruling. No sample was submitted. You state: “We are importing and exporting a Medical/Surgical Appliance, by description a Coronary Stent, which is used in Coronary Angioplasty Surgical Procedures. The Stent is delivered to the coronary lesion (blockage) by means of a Coronary Dilatation Balloon Catheter. Once the Stent is in place within the lesion, the Balloon Catheter is inflated which expands to the Stent and releases it from the Balloon Catheter and permanently affixes/implants the Stent within the coronary artery to prevent the artery from re-closing after the Balloon Catheter is removed from the body. In describing this device to the U.S. Census Commodities Analysis Division, we were led through the Schedule B until we arrived at Schedule B number 9018.39.0030, with the reasoning being that this is a Medical/Surgical Appliance, and since the Stent is delivered to the coronary lesion by means of being attached to a coronary catheter, this would likely be the correct commodity classification number. I am asking for an written ruling on this classification number, because we have also told that this Stent would fall under Schedule B Section 9021.10.0050 because a Stent is a fixed implantable device. My contention is that Section 9021 covers Orthopedic Appliances and not Coronary Surgical Appliances, and therefore the correct classification is the 9018.xx.xxxx number.” We understand your item, a Coronary Stent, to be just the precisely cut tubing, presumably made of a metal that is biologically inert, that will be expanded within the blood vessel to serve indefinitely as a support or scaffolding for it and that it does not include the apparatus necessary to get it into place and to expand it. While we agree that your items are not Orthopedic Appliances, HTS 9021, per the statutory language of the heading, includes, inter alia, Artificial Parts of the Body. Many artificial parts of the body are clearly not orthopedic appliances, e.g., artificial eyes and the tubes of synthetic fiber for replacing blood vessels, both cited in the Harmonized System Explanatory Note III to 90.21. You propose classification in HTS 9018. However, none of the hundreds of examples in the ENs to 9018 is designed to be left in the body of the patient indefinitely, as is your item. Although your item is implanted in the body, it is not considered an appliance for the purposes of 9021.90. See HRL 966874 AM, dated May 17, 2004, published in the Customs Bulletin of June 9, 2004. The applicable subheading for the Coronary Stent will be 9021.39.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for “other” artificial parts of the body and parts and accessories thereof. The rate of duty will be free. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist J. Sheridan at 646-733-3012. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division