# Cardio Systems, Inc.

- Location (FDA's records): Dallas, TX
- FDA decisions: 9 (1979–2013): 9 510(k) clearances
- Product codes: MCW (2), MJJ (1), INX (1), DWF (1), CAC (1), KRI (1), IOQ (1), FNM (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 5 (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 whose devices it cites most
- Cardiovascular Systems, Inc.: 4 (https://510kreport.com/company/cardiovascular-systems)

## Firms that cite its devices most
- Cardiovascular Systems, Inc.: 4 (https://510kreport.com/company/cardiovascular-systems)
- Cardiovascular System, Inc.: 1 (https://510kreport.com/company/cardiovascular-system)

## Its most-cited devices
- K131092: Stealth 360 Orbital Pad System (2013), cited by 4
- K081944: Modification to Diamondback 360 Degree Orbital Atherectomy System (2008), cited by 1

## Recent decisions
- K131092: Stealth 360 Orbital Pad System (Jun 24, 2013)
- K081944: Modification to Diamondback 360 Degree Orbital Atherectomy System (Aug 14, 2008)
- K972022: ZAK-2000 (Jan 22, 1998)
- K934689: Low Air Loss Mattress, Modification (Feb 2, 1994)
- K921500: Centri-Safe (TM) Valve (Sep 15, 1992)
- K882177: Add-on to Critical Patient Care Bed (Dec 1, 1988)
- K852736: Baylor Rapid Autotransfusion System (Sep 18, 1985)
- K792152: Cardioplegia Solution Admin. Set (Nov 13, 1979)

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