CLA-2-75:OT:RR:NC:N5:116
Susie Hoeger
Abbott
100 Abbott Park Road, D-03CC, AP6D-2
Abbott Park, IL 60031
RE: The tariff classification of nitinol tubing from Germany and bovine pericardium tissue from the
Netherlands
Dear Ms. Hoeger:
In your letter dated January 9, 2026, you requested a tariff classification ruling. The products to be imported
are identified as nitinol tubing and bovine pericardium tissue for use in Abbott’s Navitor™ Vision Heart
Valve. According to your submission, the nitinol (NiTi) tubing is made to ASTM F2063. This nickel alloy
tubing is seamless and cold-drawn.
Imported in addition to the nitinol tubing, is bovine pericardium tissue used in the production of the
Navitor™ Heart Valve which is part of Transcatheter Aortic Valve Implantation (TAVI) System, also
referred to as Transcatheter Aortic Valve Replacement (TAVR). TAVR is indicated for patients suffering
from severe symptomatic aortic stenosis, a permanent and chronic heart condition where the aortic valve that
controls blood flow from the heart to the rest of the body does not open fully.
In your letter, you state the bovine pericardium tissue is a raw material that is harvested from the
Netherlands. It then undergoes a multi-step series of processes in the Netherlands to prepare the tissue for
exclusive use in the Transcatheter Aortic Valve Replacement. The pericardium tissue is imported into the
United States (U.S.) under a special permit issued by the United States Department of Agriculture (USDA)
for strict use in the production of human heart valves. You claim that the importation of the bovine
pericardium tissue, in the manner in which it is imported, has no other reasonable use.
The applicable subheading for the nitinol tubing will be 7507.12.0000, Harmonized Tariff Schedule of
United States (HTSUS), which provides for nickel tubes, pipes and tube or pipe fittings (for example,
couplings, elbows, sleeves): tubes and pipes: of nickel alloys. The general rate of duty will be 2 percent ad
valorem.
The applicable subheading for the bovine pericardium tissue will be 3001.90.0190, HTSUS, which provides
for “other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified
or included: Other: Other.” The general rate of duty will be free.
You have requested consideration of the nitinol tubing and of the bovine pericardium tissue for eligibility for
preferential tariff treatment under the Nairobi Protocol. In your submission you requested 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.
The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific, and Cultural Materials
Act of 1982, established the duty-free treatment for certain articles for the handicapped. Presidential
Proclamation 5978 and Section 1121 of the Omnibus Trade and Competitiveness Act of 1988, provided for
the implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and 9817.00.96,
HTSUS. These tariff provisions specifically state that "[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
use in the foregoing article" are eligible for duty-free treatment. U.S. Note 4(a), subchapter XVII, and
accessories of braces and artificial limb prosthetics) that are specially designed or adapted for Chapter 98,
HTSUS, states that, "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(b), subchapter XVII, Chapter 98, HTSUS, which establishes limits on classification of products
in these subheadings, states as follows: (b) Subheadings 9817.00.92, 9817.00.94 and 9817.00.96 do not
cover-- (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.
The primary issue regarding the nitinol tubing and the bovine pericardium tissue in question is whether they
are parts "specifically designed or adapted" for use in the heart valve, which is specially designed or adapted
for the use or benefit of the handicapped within the meaning of the Nairobi Protocol. Although the legislative
history of the Nairobi Protocol discusses the concerns of Congress that the design, modification or adaptation
of an article must be significant so as to clearly render the article for use by handicapped individuals, no
specific definition of these terms was established by Congress. See Senate Report (Finance Committee) No.
97-564, (September 21, 1982). See also, Headquarters Ruling Letter (HRL) 951004 dated March 3, 1992.
Since it is difficult to establish a clear definition of what is “specially designed or adapted," various factors
must be utilized on a case-by-case basis to determine whether a given article is "specially designed or
adapted" within the meaning of this statute.
Regarding the subject nitinol tubing, although it will be used as a component in Abbott’s Navitor™ Vision
Heart Valve (a medical device), you state that the tubing also has many industrial uses (i.e., aerospace,
robotics, etc.). Since the tubing has many uses, this office finds that the nitinol tubing is ineligible for
duty-free treatment under subheading 9817.00.96, HTSUS.
Based on the information submitted, it is the opinion of this office that the imported bovine pericardium
tissue is a raw material that is not eligible for duty-free treatment under subheading 9817.00.96, HTSUS,
which provides for “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 article: Other.”
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 nitinol tubing, please
contact National Import Specialist (NIS) Angelia Amerson at [email protected]. If you have
any questions concerning the bovine pericardium tissue, contact NIS Judy Lee at [email protected].
Sincerely,
(for)
Denise Faingar
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division