# Cardiovascular Dynamics, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 11 (1994–1998): 11 510(k) clearances
- Product codes: LIT (6), KRA (2), ITX (2), FOZ (1)
- Predicates its devices cite: 17 (5 its own); citations of its devices by later devices: 7 (5 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
- Peripheral Systems Group: 8 (https://510kreport.com/company/peripheral-systems-group)
- Cardio-Dynamics, Inc.: 2 (https://510kreport.com/company/cardio-dynamics)
- Teleflexmedical, Inc.: 2 (https://510kreport.com/company/teleflexmedical)

## Firms that cite its devices most
- Cryo Vascular Systems, Inc.: 1 (https://510kreport.com/company/cryo-vascular-systems)
- Broncus Technologies, Inc.: 1 (https://510kreport.com/company/broncus-technologies)

## Its most-cited devices
- K944016: Focus Balloon Dilatation Catheter (1994), cited by 3
- K952064: Focus Balloon Dilatation Catheter (1995), cited by 2
- K973713: 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D. Access Vascular Access Device (Car (1998), cited by 1
- K963989: P.D. Access (Percutaneous Doppler) Vascular Access Device (1997), cited by 1

## Recent decisions
- K973713: 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D. Access Vascular Access Device (Car (Jan 23, 1998)
- K971577: Focus-PV Balloon Dilatation Catheter (Jun 18, 1997)
- K963989: P.D. Access (Percutaneous Doppler) Vascular Access Device (Apr 24, 1997)
- K963688: Focus PV Balloon Dilatation Catheter (Mar 28, 1997)
- K945693: CVD Periflow (TM) (Small Vessel) Balloon Dilatation Catheter (Aug 17, 1995)
- K952064: Focus Balloon Dilatation Catheter (Jun 21, 1995)
- K951502: CVD Bullet Infusion Catyheter (May 10, 1995)
- K951503: CVD Bullett HI-Flo Infusion Catheter (May 4, 1995)

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