Data / Medical devices / Stent, Superficial Femoral Artery
Stent, Superficial Femoral Artery (NIP): 18 FDA-registered makers in 6 countries
18 establishments in 6 countries are registered with the FDA to make Stent, Superficial Femoral Artery (product code NIP, Class 3). 14 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 12 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- NIP
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Ireland | 4 |
| Germany | 2 |
| Japan | 1 |
| Switzerland | 1 |
| Mexico | 1 |
Makers of Stent, Superficial Femoral Artery
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 | |
| Angiomed GMBH & Co. Medizintechnik KG | KARLSRUHE Baden-Wurttemberg, Germany | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Ashitaka Factory Of Terumo Corp. | FUJINOMIYA Shizuoka, Japan | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Biotronik AG | BULACH Zurich, Switzerland | Manufacturer | 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 | |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cardinal Health Mexico 244 S de RL de CV | Ciudad Juarez Chihuahua, Mexico | Manufacturer | 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 | |
| Veryan Medical Limited | Galway Galway(County), Ireland | Manufacturer, Specification developer | 0 | 1 | 0 | 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 | |
| Cook Ireland Ltd | LIMERICK Limerick(County), Ireland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CORTRONIK GmbH | Rostock-Warnemuende Mecklenburg-Western Pomerania, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Freudenberg Medical Ireland Limited | Leitrim, Ireland | Contract manufacturer | 0 | 0 | 0 | 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 2, 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.