Data / Medical devices / Stent, Superficial Femoral Artery / United States
FDA-registered makers of Stent, Superficial Femoral Artery in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Stent, Superficial Femoral Artery (product code NIP). 8 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.
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- Device
- Stent, Superficial Femoral Artery
- Product code
- NIP
- Country
- United States
Makers of Stent, Superficial Femoral Artery in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Vascular | Temecula, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 0 | 1 | 0 | 0 | api.fda.gov | |
| Abbott Vascular | Santa Clara, CA, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Maple Grove, MN, United States | Manufacturer, Manufacturer for export | 0 | 1 | 2 | 0 | api.fda.gov | |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer, Manufacturer for export | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Manufacturer for export, Specification developer | 0 | 1 | 1 | 0 | api.fda.gov | |
| W. L. Gore & Associates, Inc | Flagstaff, AZ, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| ev3, Inc. | Plymouth, MN, United States | Manufacturer, Manufacturer for export | 0 | 1 | 6 | 0 | api.fda.gov | |
| Sterigenics US LLC | Los Angeles, CA, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.