Data / Medical devices / Percutaneous Atrial Catheter Kit / United States
FDA-registered makers of Percutaneous Atrial Catheter Kit in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Percutaneous Atrial Catheter Kit (product code OFK). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Percutaneous Atrial Catheter Kit
- Product code
- OFK
- Country
- United States
Makers of Percutaneous Atrial Catheter Kit in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Corvia Medical, Inc. | Tewksbury, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vygon Usa | Lansdale, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vygon MFG | Dover, NH, United States | Manufacturer | 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.