The country of origin of nickel-titanium (NiTi) alloy stents

N358379 February 24, 2026 OT:RR:NC:N3:135 CATEGORY: Origin Lisa Murrin Expeditors Tradewin LLC 795 Jubilee Drive Peabody, MA 01960 RE: The country of origin of nickel-titanium (NiTi) alloy stents Dear Ms. Murrin: In your letter dated January 30, 2026, on behalf of your client, Confluent Medical Technologies (“CMT”), you requested a country of origin ruling on nickel-titanium (NiTi) alloy stents for purposes of the applicability of reciprocal tariffs. Additional information was provided via email dated February 12, and February 13, 2026. You describe the processing of the stent as follows: 1. Nickel and Titanium are melted and formed into bars by a manufacturer in the U.S. 2. The bar is gun drilled into a Tube Hollow by CMT in the United States and then exported to the supplier’s facility in either Germany or Costa Rica. 3. In Germany, Costa Rica, or the United States, the Tube Hollow is drawn into tubing by running several passes through machines that elongate the tube, and the process also reduces the diameter and wall thickness. Sometimes there is grinding or surface treatment to remove oxide and make it look shiny (the “Degreasing” step). The tubes undergo full annealing between the multiple drawing passes to make it formable again. The tube is then final annealed. Final annealing is the final annealing step to define mechanical properties and makes the tubes straight. 4. The drawn tubing is exported to CMT in the United States. where it is cut to length, and a unique pattern is laser cut into the tubing according to the required Stent Geometry per customer specifications for a particular part number. It is this unique pattern that determines the stent's final shape. Once laser cut, the material is dedicated to a single part number and cannot be used for anything else. It is now called an “as-cut.” It has a pre-determined end-use, to be that of a specific stent, so designated by the unique laser cut pattern of a particular part number. 5. As-cut tubes/stents are sent to Costa Rica where they are expanded by using mandrels or other tooling and undergo a heat treatment. Then they receive a chemical treatment to etch and polish the surface. Lastly, they are inspected and returned to the United States. Costa Rica Processing Details: as-cut and further processed In Costa Rica, the “as cut” stent undergoes the following processes: 1. Internal and External Surface Treatment: Honing, Tumbling, and Micro Blasting. 2. Thermal treatment processes with Salt Baths for Diameter Expansion and Transformation Temperature Set . 3. Finished Surface Properties and Surface Finish: Etching and Electropolish. 4. Quality control inspection, labeling, and packaging. You explain that the superelastic behavior of nickel–titanium (nitinol) is the key property that makes it uniquely suited for self-expandable stent applications. This behavior allows nitinol to undergo large, reversible strains through stress-induced martensitic transformation, enabling the stent to be crimped to a small diameter and subsequently recover its intended shape upon deployment in the human body. Both the laser-cut form and the final heat-treated stent exhibit superelasticity. The heat treatment performed in Costa Rica does not create superelasticity — it is already inherent in the material. Achieving superelastic behavior is heavily dependent on the alloy composition (Ni/Ti stoichiometry per ASTM F2063), which is set at the melting step performed in the United States. The heat treatment in Costa Rica changes the stiffness of the stent. The austenite finish temperature (“AF”) is a measure of the stent’s super elastic properties, and this is set during the heat treatment process in Costa Rica. The AF temperature is the point at which the material changes from the martensite phase to the austenite phase where super elastic behavior is governed by stress induced martensitic phase transformation. Essentially, in the as-cut form, the material is flexible and super elastic. However, it undergoes heat treatment and expansion in Costa Rica to obtain its final diameter and set austenite finish temperature. The stent is still flexible as it was at the laser “as-cut” state, but now it can bounce back to its specified shape after it is crimped or compressed. When determining the country of origin for purposes of applying current trade remedies under Section 301, Section 201, or Section 232, and additional duties, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter H301619, dated November 6, 2018. The test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v. United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). The manufacturing process in the United States includes melting nickel and titanium to form a bar, drilling the bar into a Tube Hollow, cutting the drawn tubing to a specific length, and laser cutting the tubing to a unique pattern according to the required Stent Geometry per customer specifications for a particular part number. These operations performed in the United States are critical as they establish the character, use, and name of the NiTi alloy stent. Subsequently, in Costa Rica, the unfinished stent undergoes internal and external surface treatments, including honing, tumbling, and micro blasting. It also receives thermal treatment processes with salt baths for diameter expansion and setting the austenite finish temperature. Additional enhancements to its finished surface properties and surface finish are achieved through etching and electropolishing. However, these operations performed in Costa Rica are considered finishing processes and do not constitute a substantial transformation of the product. Therefore, the country of origin of the NiTi alloy stent when returned from Costa Rica is the United States for the purposes of the applicability of reciprocal tariffs. Whether the NiTi alloy stent can be marked as “Made in the U.S.” or reference to U.S. content is a matter within the jurisdiction of the Federal Trade Commission (FTC) and we suggest that you contact that agency for a determination. 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) James Forkan Designated Official Performing the Duties of the Division Director National Commodity Specialist Division