The eligibility of long term hemodialysis catheters under the Nairobi Protocol from an undisclosed country

N352076
August 25, 2025
CLA-2-90:OT:RR:NC:N3:135
CATEGORY: Classification
TARIFF NO.: 9817.00.96
J. Michael Taylor King & Spalding LLP 1700 Pennsylvania Avenue Washington, DC 20006 RE: The eligibility of long term hemodialysis catheters under the Nairobi Protocol from an undisclosed country Dear Mr. Taylor: In your letter dated August 6, 2025, you requested a tariff classification ruling on behalf of your client Teleflex LLC. The items under consideration are hemodialysis catheters, Arrow Edge Hemodialysis Catheter (“Arrow Edge”), as well as Arrow-Clark Vector Flow Antegrade Chronic Hemodialysis Catheter (“Arrow-Clark Antegrade”) and the Arrow-Clark Vector Flow Retrograde Hemodialysis Catheter (“Arrow-Clark Retrograde”) (collectively “Arrow-Clarks”). The catheters are two-lumen polyurethane central venous catheters designed for long term vascular access for hemodialysis and apheresis. All three catheters perform the same function and achieve the same medical outcome but use different placement techniques and have different tip designs. The Arrow Edge is designed to provide optimal performance by delivering high flow rates, up to 400 cubic centimeters (“cc”) per minute, at low pressures. The crescent-shape of the catheter’s distal V- tip is designed to promote blood flow even if the tip is resting against the vessel wall. The Arrow-Clarks are symmetrical-tip, tunneled hemodialysis catheters designed to provide sustained high flows, reduce loss of lock solution, and reduce the risk of thrombus accumulation due to platelet activation resulting from shear stress. Available in both retrograde and antegrade insertion platforms, Arrow-Clarks are designed with an innovative tip that allows placement flexibility with minimal impact on recirculation rates. The three catheters are inserted percutaneously and are preferentially placed into the internal jugular vein. They primarily are intended for individuals with end stage renal disease (“ESRD”). You state the catheters, are intended for the long-term and repeated removal of waste, toxins, and excess fluids from the blood during hemodialysis treatment, have no alternative application, are sold only to medical facilities for use by licensed medical professionals, and are distributed through medical device channels for ESRD treatment. In your submission you requested consideration of a classification under 9817.00.96, Harmonized Schedule of the United States, (HTSUS), which applies to articles and parts and accessories of articles specifically

designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped. Subheading 9817.00.96, HTSUS, covers: “[a]rticles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles: [o]ther.” The term “blind or other physically or mentally handicapped persons” includes “any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS. Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent greater than in other cases or towards others” and “designed” means something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then, whether “those persons [are] physically handicapped [].” Sigvaris, 899 F.3d at 1314. The Court of Appeals for the Federal Circuit CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be “specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons to an extent greater than for the use or benefit of others” and adopted the five factors used by U.S. Customs and Border Protection (CBP): (1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by properties of the design, form, and the corresponding use specific to this unique design, from articles useful to non-handicapped persons); (2) whether any characteristics are present that create a substantial probability of use by the chronically handicapped so that the article is easily distinguishable from articles useful to the general public and any use thereof by the general public is so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or distributors recognized or proven to be involved in this class or kind of articles for the handicapped; (4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5) whether the condition of the articles at the time of importation indicates that these articles are for the handicapped. In Headquarters Ruling HQ 964676, dated January 7, 2002, CBP determined that the specially produced P.E.S./P.E.T. bundles used in dialyzers for the treatment of chronic renal failure qualified for duty free treatment under subheading 9817.00.96, HTSUS. In the ruling, CBP confirmed that people who suffer from end-stage renal failure were considered handicapped, and articles specifically designed almost exclusively for their benefit were classifiable as articles for the handicapped, as established in Travenol Laboratories, Inc. v. United States, 813 F. Supp. 840, 844 (CIT 1993). You explain that the three chronic hemodialysis catheters are substantially comparable to the AV fistula cannula deemed Nairobi Protocol qualifying by the CIT in Travenol. In fact, an AV fistula cannula is an alternative to a chronic hemodialysis catheter for individuals with ESRD. The main difference between the two products is that the AV fistula cannula is accessed with large bore needles to connect to a dialysis machine, whereas the chronic catheter has external catheter lumens that connect to a dialysis machine. In addition, the AV fistula cannula is intended for temporary use (i.e., used in each dialysis session), while the chronic hemodialysis catheters (the subject of this ruling request) are intended for use for longer periods of time (i.e., weeks to months). Based on the information supplied and the relevant precedent, it is the opinion of this office that the above hemodialysis catheters qualify for duty-free treatment in subheading 9817.00.96, HTSUS.

The tariffs and additional duties cited above are current as of this ruling’s issuance. 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 at https://hts.usitc.gov/. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection 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, please contact National Import Specialist Fei Chen at [email protected].
Sincerely,
(for) James Forkan Acting Director National Commodity Specialist Division