# Cardio-Dynamics, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 4 (1994–1995): 4 510(k) clearances
- Product codes: LIT (3), FOZ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Cardiovascular Dynamics, Inc.: 2 (https://510kreport.com/company/cardiovascular-dynamics)
- E-Med Corp.: 1 (https://510kreport.com/company/e-med)

## Its most-cited devices
- K954313: Focus PC Balloon Dilatation Catheter (1995), cited by 2
- K931027: Bullett Peripheral Infusion Catheter (1994), cited by 1

## Recent decisions
- K954313: Focus PC Balloon Dilatation Catheter (Dec 1, 1995)
- K945943: CVD Periflow (TM) Balloon Dilatation Catheter (Feb 24, 1995)
- K942150: CVD Small Vessel Balloon Dilation Catheter (Aug 2, 1994)
- K931027: Bullett Peripheral Infusion Catheter (Feb 4, 1994)

Source page: https://510kreport.com/company/cardio-dynamics