510(k) K181122 ยท DSP System, Balloon, Intra-Aortic And Control
CARDIOSAVE Intra-Aortic Balloon Pump
| Applicant | Datascope Corp., Manwah NJ, US |
| Decision | Substantially Equivalent, May 31, 2018 |
| Received | Apr 30, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181122
| 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 Hybrid. Intra-Aortic Balloon Pump system. Open, Classified |
DSP | None listed |
| Sep 20, 2024 | Datascope Corp. CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. Open, Classified |
DSP | None listed |
| Sep 20, 2024 | Datascope Corp. CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. Open, Classified |
DSP | None listed |
| Sep 20, 2024 | Datascope Corp. CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. Open, Classified |
DSP | None listed |
| Sep 20, 2024 | Datascope Corp. CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. Open, Classified |
DSP | None listed |
| Aug 31, 2023 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45 Open, Classified |
DSP | None listed |
| Aug 31, 2023 | Datascope Corp. Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 Open, Classified |
DSP | None listed |
| Aug 30, 2023 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45 Open, Classified |
DSP | None listed |
| Aug 30, 2023 | Datascope Corp. Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 Open, Classified |
DSP | None listed |
| Aug 30, 2023 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45 Open, Classified |
DSP | None listed |
| Aug 30, 2023 | Datascope Corp. Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 Open, Classified |
DSP | None listed |
| Aug 30, 2023 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45 Open, Classified |
DSP | None listed |
| Aug 30, 2023 | Datascope Corp. Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85, Open, Classified |
DSP | None listed |
| Aug 30, 2023 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45 Open, Classified |
DSP | None listed |
| Aug 30, 2023 | Datascope Corp. Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 Open, Classified |
DSP | None listed |
| Jul 20, 2023 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers
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
0998- Open, Classified |
DSP | None listed |
| Jul 20, 2023 | Datascope Corp. Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers
0998-00-0800-75
0998-00-0800-83
0998-00-0800-85 Open, Classified |
DSP | None listed |
| Jul 19, 2023 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers
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
0998- Open, Classified |
DSP | None listed |
| Jul 19, 2023 | Datascope Corp. Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers
0998-00-0800-75
0998-00-0800-83
0998-00-0800-85 Open, Classified |
DSP | None listed |
| Mar 9, 2023 | Datascope Corp. Cardiosave Hybrid
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
0998-00-0800-55
0998-00-0800-65
0998-UC-0 Open, Classified |
DSP | None listed |
| Mar 9, 2023 | Datascope Corp. Cardiosave Rescue
Model Nos.
0998-00-0800-75
0998-00-0800-83
0998-00-0800-85 Open, Classified |
DSP | None listed |
| Mar 6, 2023 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998 Open, Classified |
DSP | None listed |
| Mar 6, 2023 | Datascope Corp. Cardiosave Rescue. Model Number: 0998-00-0800-83. Open, Classified |
DSP | None listed |
| Jan 19, 2023 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52 Open, Classified |
DSP | None listed |
| Jan 19, 2023 | Datascope Corp. Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 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 Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 Open, Classified |
DSP | None listed |
| Sep 8, 2021 | Datascope Corp. Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 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 |
| Oct 27, 2018 | Maquet Datascope Corp - Cardiac Assist Division Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 Open, Classified |
DSP | None listed |
| Oct 27, 2018 | Maquet Datascope Corp - Cardiac Assist Division Cardiosave Rescue IABP, Part Number 0998-UC-0800-83 Open, Classified |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.