CLA-2-98:OT:RR:NC:N3:135

Daryl Clark
Martech Medical Products, Inc.
1500 Delp Dr.
Harleysville, PA 19438

RE: The eligibility of long term hemodialysis catheters under the Nairobi Protocol treatment from Mexico

Dear Mr. Clark:

In your letter dated May 16, 2025, you requested a tariff classification ruling for the following long-term hemodialysis catheters: Hemo Cath® LT Catheter, Split Cath® III Catheter, Tesio® Catheter, Duo-Jet®II Chronic Twinline Catheter, Split Stream® Catheter, and Canaud Catheter. They are designed specifically for use in patients with chronic kidney disease requiring ongoing hemodialysis. Additional information was provided via email dated July 14 and July 21, 2025.

The Hemo Cath® LT Catheter is a double lumen, single access catheter that is used to remove and return blood through two separate passages (venous and arterial lumens). It is available in 8F, 10F, and 12.5F straight configurations, as well as a pre-curved option, all featuring a step-tip design which refers to the staggered configuration in which the venous lumen extends further distally than the arterial lumen at the tip of the tube. Each lumen is connected through an extension line. The transition between lumen and extension is housed within a molded hub. Each lumen has the priming volume identified by identification rings assembled into the clamps on the extensions. A polyester Dacron cuff is placed on the catheter’s lumen for tissue ingrowth to anchor the catheter. The catheter incorporates barium sulphate to facilitate visualization under fluoroscopy or x-ray. It also includes a suture wing, two sleeves, and two Luer-Lok connectors.

The Split Cath® III Catheter (straight and pre-curve) is a double lumen, single access catheter that is used to remove and return blood through two separate passages (venous and arterial lumens). It utilizes a split-tip design which refers to the configuration where the distal end of the catheter is divided into two separate tips. The venous lumen is positioned slightly further than the arterial lumen of the catheter. Each lumen is connected through an extension line. The transition between lumen and extension is housed within a molded hub. Each lumen has the priming volume identified by identification rings assembled into the clamps on the extensions. A polyester Dacron cuff is placed on the catheter’s lumen for tissue ingrowth to anchor the catheter. The catheter incorporates barium sulphate to facilitate visualization under fluoroscopy or x-ray. It also includes a rotatable suture wing, two sleeves, and two Luer-Lok connectors. The Tesio® Catheter is a single-lumen catheter available in 40 cm and 70 cm assembled versions, and a 40 cm unassembled version inserted into the target vein that is used to remove or return blood. It utilizes a round lumen tip design which refers to the rounded, smooth arterial lumen or venous lumen tip of the catheter. The body of the catheter has depth markings and a Dacon cuff. The catheter includes a separate arterial or venous extension set, color-coded for identification (red for arterial and blue for venous), which consists of a hub, a tube, a clamp, an ID ring, and a Luer-Lok connector. The catheter incorporates barium sulphate to facilitate visualization under fluoroscopy or x-ray.

Duo-Jet®II Chronic Twinline Catheter is similar to the The Tesio® Catheter but the body of the catheter also contains designated priming volume lines.

The Split Stream® Catheter Slip-Tip Design is a double lumen, single access catheter that is used to remove and return blood through two separate passages (venous and arterial lumens). The lumens are connected to two extensions by means of detachable adaptor style hubs. Priming volumes are printed on each lumen. A polyester Dacon cuff is placed on the catheter’s lumen for tissue ingrowth to anchor the catheter. The catheter incorporates barium sulphate to facilitate visualization under fluoroscopy or x-ray. It also includes a suture wing, two sleeves, two clamps, two ID rings, and two Luer-Lok connectors.

The Canaud Catheter Independent Round Lumen Design is a single lumen catheter inserted into the target vein that is used to remove or return blood. The body of the catheter has depth markings. The catheter includes a separate arterial or venous extension set, color-coded for identification (red for arterial and blue for venous), which consists of a hub, a tube, a clamp, a sleeve, and a Luer-Lok connector. You describe that the subcutaneous portion of the adaptor has a barbed stem for attachment to the subcutaneous lumen. A suture, attached to each adaptor, is used to anchor the catheter within the tunnel. However, the above description is not shown in the diagram. The catheter incorporates barium sulphate to facilitate visualization under fluoroscopy or x-ray.

You state the long-term hemodialysis catheters are tunneled, cuffed, and that the dual-lumen central venous access devices are designed for the repeated delivery and return of blood during chronic hemodialysis treatment in patents in end stage renal disease (ESRD), a chronic kidney disease. These devices are unsuitable for temporary use in acute or transient renal failure cases due to the Dacron cuff facilitating tissue ingrowth and for securing the catheter in place over time. They are labeled explicitly for hemodialysis access and have no viable off-label or alternative application. The devices are sold only to hospitals, nephrologists, and dialysis clinics and distributed through medical device channels exclusively for ESRD treatment.

In your submission you requested consideration of a classification under 9817.00.96, 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 9817.00.60, 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). 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