# Vortex Medical, Inc.

- Location (FDA's records): Norwell, MA
- FDA decisions: 3 (2009–2014): 3 510(k) clearances
- Product codes: DWF (2), DWE (1)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Terumo Cardiovascular Systems Corp.: 2 (https://510kreport.com/company/terumo-cardiovascular-systems)
- Gish Biomedical, Inc.: 2 (https://510kreport.com/company/gish-biomedical)
- Cobe Laboratories, Inc.: 2 (https://510kreport.com/company/cobe-laboratories)
- Maquet Cardiopulmonary, AG: 1 (https://510kreport.com/company/maquet-cardiopulmonary)

## Firms that cite its devices most
- AngioDynamics, Inc.: 2 (https://510kreport.com/company/angiodynamics)

## Its most-cited devices
- K091304: Vortex Cannula (2009), cited by 1
- K092486: Vortex Medical Angiovac Cardiopulmonary Bypass Circuit (2009), cited by 1
- K133445: Angiovac Cannula (2014), cited by 1

## Recent decisions
- K133445: Angiovac Cannula (Mar 5, 2014)
- K092486: Vortex Medical Angiovac Cardiopulmonary Bypass Circuit (Aug 28, 2009)
- K091304: Vortex Cannula (Jul 2, 2009)

Source page: https://510kreport.com/company/vortex-medical