Data / Medical devices / Catheter Introducer Kit / United States
FDA-registered makers of Catheter Introducer Kit in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Catheter Introducer Kit (product code OFC). 1 has a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Catheter Introducer Kit
- Product code
- OFC
- Country
- United States
Makers of Catheter Introducer Kit in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Spectranetics Corp. | Colorado Springs, CO, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | March 26, 2010 | 0 | 0 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mainstream Medical Devices | Austin, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PFM Medical, Inc | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prytime Medical Devices, Inc. | Lakewood, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prytime Medical Devices, Inc. | Boerne, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Vascular Solutions LLC | Maple Grove, MN, United States | Repackager or relabeler, Specification developer | 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 | |
| Zien Medical Technologies LLC | Salt Lake City, UT, United States | Manufacturer | 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.