510(k) K163542 ยท DSP System, Balloon, Intra-Aortic And Control
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
| Applicant | Datascope Corp., Manwah NJ, US |
| Decision | Substantially Equivalent, Jan 31, 2017 |
| Received | Dec 16, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163542
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2025 | Datascope Corp. Cardiosave Hybrid Open, Classified |
DSP | None listed |
| Dec 16, 2025 | Datascope Corp. Cardiosave Rescue Open, Classified |
DSP | None listed |
| Dec 11, 2025 | Datascope Corp. Cardiosave Rescue. Intra-Aortic Balloon Pump system. Open, Classified |
DSP | None listed |
| Dec 30, 2021 | Datascope Corp. Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998- Open, Classified |
DSP | None listed |
| Dec 30, 2021 | Datascope Corp. Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85. Open, Classified |
DSP | None listed |
| Oct 20, 2021 | Datascope Corp. Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers.
1. Cardiosave Hybrid. Model Numbers: 0998-00- Open, Classified |
DSP | None listed |
| Oct 7, 2021 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0 Open, Classified |
DSP | None listed |
| Sep 8, 2021 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0 Open, Classified |
DSP | None listed |
| Apr 28, 2021 | Datascope Corp. Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998 Open, Classified |
DSP | None listed |
| Apr 28, 2021 | Datascope Corp. Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998 Open, Classified |
DSP | None listed |
| Jul 16, 2019 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53
For cardiovascular use. Open, Classified |
DSP | None listed |
| Jul 16, 2019 | Datascope Corp. Cardiosave Rescue IABP, 0998-00-0800-83
Intra-Aortic Balloon Pump
For cardiovascular use. Open, Classified |
DSP | None listed |
| Jul 16, 2019 | Datascope Corp. CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53
For cardiovascular use. Open, Classified |
DSP | None listed |
| Jul 16, 2019 | Datascope Corp. CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55
For cardiovascular use. Open, Classified |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.