CLA-2-90:OT:RR:NC:N4:405
Mark Pinchok
Bayer International Trade Services Corporation
651 Colliers Way, Suite 414
Weirton, WV 26062
RE: The tariff classification and country of origin of a coated balloon catheter.
Dear Mr. Pinchok:
In your letter dated July 13, 2011, on behalf of MEDRAD, Inc., you requested a tariff classification ruling. No sample was provided.
The merchandise at issue is referred to as the Cotavance Paclitaxel Coated Balloon Angioplasty Catheter. You state that the intended use of the Cotavance is for mechanical/balloon dilation of stenotic lesions in the iliac and infrainguinal arteries while applying the antiproliferative drug Paclitaxel to inhibit restenosis. The Cotavance consists of a balloon catheter that is coated with a drug matrix consisting of Paclitaxel and Ultravist (Paclitaxel is the active ingredient and Ultravist is a contrast imaging agent; the drug matrix is referred to by the trade name Paccocath®).
The Cotavance is used like a standard angioplasty balloon catheter. When the catheter is inserted into a blood vessel and inflated to dilate it, the anti-restenotic drug matrix coating the balloon is released directly to the diseased area (restenosis is the reoccurrence of stenosis, which is the narrowing of the blood vessel). The purpose of coating the balloon catheter with the drug matrix is to keep the affected blood vessels open wider and longer than would normally be the case after a standard angioplasty procedure (i.e. one performed by an uncoated balloon catheter). Catheters are provided for, eo nomine, in Subheading 9018.39, HTSUS. While the Cotavance differs from a standard catheter in that it is coated with a drug matrix, this would not be enough to classify the article elsewhere in the tariff. The Paccocath® drug matrix undoubtedly plays a role in the angioplasty procedure, however it is the balloon catheter that is inserted into the body and it is the inflation of that balloon catheter that opens up the narrowed or blocked blood vessel. The drug matrix may treat the recently opened vessel to prevent restenosis, but the matrix has no role in clearing a blocked blood vessel. It should also be noted that Customs has previously ruled upon coated and “drug eluting” stents, designed to be implanted into a patient’s artery after an angioplasty procedure, specifically in New York Ruling Letters J85317 and N076947, dated June 25, 2003, and October 19, 2009 respectively. In both cases, the classification of the stents was in HTSUS Chapter 90 and was not based on the pharmaceuticals they were coated with.
Although an angioplasty balloon catheter is performing a different function than, e.g., a urinary balloon catheter, in which the balloon is inflated to prevent the indwelling catheter through which the urine will flow from slipping out, the subheading above HTSUS 9018.31-.39 includes “catheters … and the like.”
We agree that the applicable subheading for the Cotavance coated balloon angioplasty catheter will be 9018.39.0040, Harmonized Tariff Schedule of the United States (HTSUS), which provides for, inter alia, catheters, other than rubber catheters. The rate of duty will be free. In your submission you also request a ruling on the country of origin for the Cotavance coated
balloon catheter.
Since it is clear that you do not import any finished, coated balloon catheters, but perform various assembly and other processes in the USA on parts and ingredients thereof, their country of origin for CBP purposes is moot.
You indicate that you believe that the country of origin of the finished coated balloon catheters is the United States. The question of whether their labeling may consist of or include the phrase “Product of USA” is under the jurisdiction of the Federal Trade Commission (FTC), which may be contacted for advice at 6th & Pennsylvania Avenue, N.W., Washington, D.C. 20580.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.
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