# Flowmedica, Inc.

- Location (FDA's records): Fremont, CA
- FDA decisions: 3 (2004–2008): 3 510(k) clearances
- Product codes: KRA (3)
- Predicates its devices cite: 10 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Arrow Intl., Inc.: 2 (https://510kreport.com/company/arrow-intl)
- Interventional Innovations Corp.: 1 (https://510kreport.com/company/interventional-innovations)
- Ekos Corp.: 1 (https://510kreport.com/company/ekos)
- Medi-Tech, Inc.: 1 (https://510kreport.com/company/medi-tech)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)

## Its most-cited devices
- K050205: Benephit Bifurcated Infusion Catheter and 5FR. Introducer Sheath (2005), cited by 1
- K033569: Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath (2004), cited by 1

## Recent decisions
- K082163: Flowmedica Benephit Infusion Systems (Oct 29, 2008)
- K050205: Benephit Bifurcated Infusion Catheter and 5FR. Introducer Sheath (Mar 4, 2005)
- K033569: Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath (Jan 13, 2004)

Source page: https://510kreport.com/company/flowmedica
