The eligibility of stylets under the Nairobi Protocol treatment from Switzerland

N355640 November 25, 2025 CLA-2-90:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9817.00.96 Douglas Saker LE Coppersmith LLC 525 South Douglas Street, Suite 100 El Segundo, CA 90245 RE: The eligibility of stylets under the Nairobi Protocol treatment from Switzerland Dear Mr. Saker: In your letter dated November 3, 2025, you requested a tariff classification ruling on behalf of your client, PRO-TECH Design and Manufacturing Inc. Additional information was provided by email dated November 20, 2025. Three types of Heraeus Stylets — J-shaped, Straight, and Tapered — used for the Abbott pacemaker implant procedure are identified in your ruling request. All consist of metal wire and knobs or buttons. You explain that the stylets are precision-engineered components designed exclusively for use with Abbott’s bradycardia, tachycardia, and cardiac resynchronization therapy (CRT) leads. They are not general-purpose accessories; they are custom fabricated to meet the exact mechanical and procedural requirements of Abbott’s lead systems and are not compatible with any other manufacturer’s products. Each stylet is manufactured from medical-grade wire and is engineered to match the specific length and stiffness profile required for the corresponding Abbott lead. The wire includes a distal tip ground profile, which creates a custom taper that enhances steerability and control during implantation. This taper is critical for navigating the venous system and achieving precise placement within the heart. In addition, certain stylets feature specialized ball tips that are designed to interact with unique internal features of Abbott leads. These design elements ensure that the stylet and lead function as an integrated system, enabling accurate delivery and stable positioning of the lead during cardiac implantation procedures. The stylets are essential to the function of Abbott’s stylet-driven lead systems, which rely on the internal support and steerability provided by the stylet to reach the targeted implant site. These stylets are not used independently or in any other medical or non-medical applications. Their design, material composition, and functional characteristics are all tailored to the specific requirements of Abbott’s cardiac leads, making them integral to the safe and effective delivery of therapy. In your submission you requested consideration of a classification under 9817.00.96, Harmonized Tariff 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: “Articles 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 . . . Other.” 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 Rulings Letters (“HQ”) 557025, dated March 17, 1993, and HQ 557027, dated March 17, 1993, CBP concluded that individuals suffering from heart problems which mandated the use of pacemakers were considered physically handicapped. The Heraeus Stylets are specially designed for use in the Abbott pacemaker implant procedure, helping to deliver the pacemaker leads to the target implant location to provide therapies for cardiac rhythm disorders (such as bradycardia or tachycardia). They 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 fei.chen@cbp.dhs.gov. Sincerely, (for) Deborah Marinucci Designated Official Performing the Duties of the Division Director National Commodity Specialist Division