# Cardiovascular System, Inc.

- Location (FDA's records): Saint Paul, MN
- FDA decisions: 1 (2015–2015): 1 510(k) clearance
- Product codes: MCW (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 2 (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)
- Cardio Systems, Inc.: 1 (https://510kreport.com/company/cardio-systems)

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

## Its most-cited devices
- K151260: ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD (2015), cited by 1

## Recent decisions
- K151260: ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD (Jun 10, 2015)

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