Balloon Shaft for drug infusion balloon catheter; medical instruments and appliances; NY 882361; EN 90.18; GRI 2(a)

HQ 953545 May 10, 1993 CLA-2 CO:R:C:M 953545 LTO CATEGORY: Classification TARIFF NO.: 9018.90.80 Mr. David P. Lang Novacon Corporation 2514 7th Avenue, E. Suite 11 St. Paul, Minnesota 55109 RE: Balloon Shaft for drug infusion balloon catheter; medical instruments and appliances; NY 882361; EN 90.18; GRI 2(a) Dear Mr. Lang: This is in response to your letter of March 1, 1993, requesting reconsideration of NY 882361, dated February 24, 1993, which concerned the classification of a balloon shaft, which is a part of a "Drug Infusion Balloon Catheter," under the Harmonized Tariff Schedule of the United States (HTSUS). FACTS: The article in question is a balloon shaft, which is a part of a drug infusion balloon catheter. After importation, a three- way stopcock, extension tubing and luer connecter are assembled to the balloon shaft to form a complete drug infusion balloon catheter. The drug infusion balloon catheter is connected to an indwelling catheter. The balloon catheter is used primarily by home patients who are required to take daily dosages of a physician prescribed drug (i.e., anti-biotics, chemotherapy, analgesics). It is attached to an extension tube which is then connected to an indwelling catheter. The medical preparation to be administered is introduced into the top opening of the shaft. The preparation fills and inflates the balloon, and is then gradually fed to the patient by pressure from the balloon. The rate of flow is regulated by the stopcock and the type of balloon used. The submitted sample measures 3 3/4 inches in overall - 2 - length. It consists of a shaft with an opening and hinged cap at one end, a balloon covering the middle section, and a Luer-Lok connection at the other end. In NY 882361, the article in question was held to be classifiable under subheading 9018.90.80, HTSUS, which provides for other instruments and appliances used in medical, surgical, dental or veterinary sciences. ISSUE: Whether the drug infusion balloon catheter is classifiable as other instruments and appliances used in medical, surgical, dental or veterinary sciences under subheading 9018.90.80, HTSUS. LAW AND ANALYSIS: The General Rules of Interpretation (GRI's) to the HTSUS govern the classification of goods in the tariff schedule. GRI 1 states in pertinent part that "for legal purposes, classification shall be determined according to the terms of the headings and any relative section or chapter notes . . . ." You have asked us to reconsider the classification of the articles in question under subheading 9018.90.80, HTSUS, which provides for other instruments and appliances used in medical sciences, and parts thereof. The Harmonized Commodity Description and Coding System Explanatory Notes (EN) constitute the Customs Co-operation Council's official interpretation of the Harmonized System. While not legally binding, the ENs provide a commentary on the scope of each heading of the Harmonized System, and are generally indicative of the proper interpretation of these headings. EN 90.18, pg. 1487, states that heading 9018, HTSUS, "covers a very wide range of instruments and appliances which, in the vast majority of cases, are used only in professional practice (e.g., by doctors, surgeons, dentists, veterinary surgeons, midwives), either to make a diagnosis, to prevent or treat an illness or to operate, etc." The notes, pgs. 1488-9, indicate that the heading includes the following instruments and appliances for human medicine or surgery: needles; lancets; trocars; surgical knives and scalpels; sounds; specula; mirrors and reflectors; scissors; shears; forceps; pliers; chisels; gouges; mallets; hammers; saws; scrappers; cannulae; catheters; suction tubes; cauteries; tweezers; dressing, swab, sponge or needle holders; retractors; dilators; clips; and syringes. The fact that, as imported, the article in question is not complete, functional or saleable does not control its - 3 - classification. First, heading 9018, HTSUS, covers both parts and accessories for medical instruments and appliances. Second, GRI 2(a) states that "[a]ny reference in a heading to an article shall be taken to include a reference to that article incomplete or unfinished, provided that, as entered, the incomplete or unfinished article has the essential character of the complete or finished article." Accordingly, if the balloon shafts have the essential character of the complete drug infusion balloon catheter, they are classifiable under subheading 9018.90.80, HTSUS, as other medical instruments and appliances. If the balloon shafts do not have the essential character of the complete article, they would remain classifiable under subheading 9018.90.80, HTSUS, as a part for other medical instruments and appliances. Because the importation in question does not consist of the portion of the drug infusion balloon catheter that provides the connection to the patient, nor does it consist of the catheter's regulating mechanism, the balloon shaft does not have the essential character of the complete article. Therefore, the article in question is classifiable as a part of other medical instruments and appliances. HOLDING: The balloon shaft for the drug infusion balloon catheter is classifiable under subheading 9018.90.80, HTSUS, which provides for other instruments and appliances used in medical, surgical, dental or veterinary sciences, and parts thereof. The corresponding rate of duty for articles of this subheading is 7.9% ad valorem. NY 882361, dated February 24, 1993, is affirmed. Sincerely, John Durant, Director