# Datascope Corp., Cardiac Assist Division

- Location (FDA's records): Fairfield, NJ
- FDA decisions: 4 (2009–2012): 4 510(k) clearances
- Product codes: DSP (3), DXC (1)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 5 (1 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Datascope Corp.: 5 (https://510kreport.com/company/datascope)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)
- Cardiac Assist, Maquet Cardiovascular, LLC: 1 (https://510kreport.com/company/cardiac-assist-maquet-cardiovascular)

## Firms that cite its devices most
- Cardiac Assist, Maquet Cardiovascular, LLC: 1 (https://510kreport.com/company/cardiac-assist-maquet-cardiovascular)
- Marine Polymer Technologies, Inc.: 1 (https://510kreport.com/company/marine-polymer-technologies)
- Jilin Coronado Medical, Ltd.: 1 (https://510kreport.com/company/jilin-coronado-medical)
- Datascope Corp.: 1 (https://510kreport.com/company/datascope)

## Its most-cited devices
- K091449: Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02 (2009), cited by 2
- K122405: Air-Band Radial Compression Device (2012), cited by 2
- K120868: Mega (TM) 7.5FR. 30CC Intra-Aortic Balloon Catheter and Accessories, Mega (TM) 7.5FR. 40CC Intra-Aortic Balloon Catheter (2012), cited by 1

## Recent decisions
- K122405: Air-Band Radial Compression Device (Nov 9, 2012)
- K122628: Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and Accessories (Sep 6, 2012)
- K120868: Mega (TM) 7.5FR. 30CC Intra-Aortic Balloon Catheter and Accessories, Mega (TM) 7.5FR. 40CC Intra-Aortic Balloon Catheter (Apr 20, 2012)
- K091449: Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02 (Jun 18, 2009)

Source page: https://510kreport.com/company/datascope-cardiac-assist-division