# Cardiac Assist, Maquet Cardiovascular, LLC

- Location (FDA's records): Manwah, NJ
- FDA decisions: 2 (2011–2011): 2 510(k) clearances
- Product codes: DSP (2)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 32 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Datascope Corp.: 2 (https://510kreport.com/company/datascope)
- Datascope Corp., Cardiac Assist Division: 1 (https://510kreport.com/company/datascope-cardiac-assist-division)

## Firms that cite its devices most
- Datascope Corp.: 3 (https://510kreport.com/company/datascope)
- Datascope Corp., Cardiac Assist Division: 1 (https://510kreport.com/company/datascope-cardiac-assist-division)

## Its most-cited devices
- K112327: Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories (2011), cited by 2
- K112372: Cardiosave Hybrid Intra-Aortic Balloon Pump (2011), cited by 2

## Recent decisions
- K112372: Cardiosave Hybrid Intra-Aortic Balloon Pump (Sep 15, 2011)
- K112327: Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories (Sep 9, 2011)

Source page: https://510kreport.com/company/cardiac-assist-maquet-cardiovascular