# Evalve, Inc.

- Location (FDA's records): Menlo Park, CA
- FDA decisions: 4 (2009–2010): 4 510(k) clearances
- Product codes: DRA (4)
- Predicates its devices cite: 11 (6 its own); citations of its devices by later devices: 15 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Velocimed, Inc.: 1 (https://510kreport.com/company/velocimed)
- Nmt Medical, Inc.: 1 (https://510kreport.com/company/nmt-medical)
- Appriva Medical, Inc.: 1 (https://510kreport.com/company/appriva-medical)
- Arrow Intl., Inc.: 1 (https://510kreport.com/company/arrow-intl)
- St Jude Medical: 1 (https://510kreport.com/company/st-jude-medical)

## Firms that cite its devices most
- Abbott Vascular: 8 (https://510kreport.com/company/abbott-vascular)
- Cardiosolutions, Inc.: 1 (https://510kreport.com/company/cardiosolutions)

## Its most-cited devices
- K083793: Steerable Guide Catheter (2009), cited by 5
- K091596: Evalve Steerable Guide Catheter, Model SGC01ST (2009), cited by 4
- K093866: Evalve Steerable Guide Catheter (2010), cited by 3
- K100789: Modificaton to: Steerable Guide Catheter, Model SGC01ST (2010), cited by 3

## Recent decisions
- K100789: Modificaton to: Steerable Guide Catheter, Model SGC01ST (Apr 21, 2010)
- K093866: Evalve Steerable Guide Catheter (Jan 13, 2010)
- K091596: Evalve Steerable Guide Catheter, Model SGC01ST (Jul 2, 2009)
- K083793: Steerable Guide Catheter (Apr 27, 2009)

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