The tariff classification of a Balloon Suction Catheter and a Lap-Band from Costa Rica

N005435 January 30, 2007 CLA-2-90:RR:E:NC:N1:105 CATEGORY: Classification TARIFF NO.: 9021.39.00, 9021.90.8000 Ms. Iliana G. Fuller Allergan Sales, LLC 2525 Dupont Drive Irvine, CA 92623 RE: The tariff classification of a Balloon Suction Catheter and a Lap-Band from Costa Rica Dear Ms. Fuller: In your letter dated January 12, 2007, you requested a tariff classification ruling. Regarding the Lap-Band, you state: “BioEnterics( is a silicone elastomer ring designed to be placed around the upper part of the stomach and filled with saline on the inner surface. This creates a new small stomach pouch and leaves the larger part of the stomach below the band so the food storage area in the stomach is reduced, and the pouch above the band can hold only a small amount of food. The band is connected by tubing to an access port that is placed beneath the skin during surgery. Later, the surgeon can change the stomach size by adding or subtracting saline inside the inner balloon through the access port. The LAP-BAND system is usually placed laparoscopically, or using “keyhole” surgery, which offers the advantages of reduced pain, length of hospital stay and recovery period. The BioEnterics( system and accessories do not contain latex or natural rubber materials.” Regarding the Balloon Suction Catheter, you state: “BioEnterics( Gastric Balloon Suction Catheter is an accessory used for suction/decompression of the stomach, pouch identification/sizing and irrigation during gastric and bariatric surgical procedures. It is a flexible gastric tube that does not contain latex or natural rubber materials.” Per the attached INAMED page, “ The dual silicone lumen Gastric Balloon Suction Cathether utilizes one lumen for drainage, suction and irrigation and the second lumen to inflate//deflate the fixation/calibration balloon.” We note that silicone is not a rubber for the purposes of the HTSUS. You propose classification for both in HTSUS (2007) 9021.90.8100. However, the catheter is not worn nor carried nor implanted in the body. It is used only temporarily by the surgical team during various gastric and bariatric surgeries. A Foley balloon catheter was classified in HTSUS 9018.39.00 per HRL (Headquarters Ruling Letter) 963165, 2-8-01. The applicable subheading for the Lap-Band will be 9021.90.8000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "other" Appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability and parts and accessories thereof. The rate of duty will be free.                                  The applicable subheading for the Balloon Suction Catheter will be 9021.39.00, Harmonized Tariff Schedule of the United States (HTSUS), which provides for, inter alia, catheters, cannulae and the like and the parts and accessories thereof. The rate of duty will be free. 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). Pursuant to title 19 United States Code, Section 3005 The Harmonized Tariff Schedule of the United States is in the process of being amended to reflect changes recommended by the World Customs Organization. The amendments are expected to affect the classification of your merchandise. On January 4, 2007, Presidential Proclamation 8097 containing these changes was published in the Federal Register. See 72 FR 453, Volume 72, No. 2. The proclaimed changes are effective for goods entered or withdrawn from warehouse for consumption on or after February 3, 2007. Once those changes are in effect, it is anticipated that the BioEnterics Lap-Band will be classified in 9021.90.8100 HTSUS. 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