510(k) K031636 ยท DSP System, Balloon, Intra-Aortic And Control
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
| Applicant | Datascope Corp., Mahwh NJ, US |
| Decision | Substantially Equivalent, Aug 11, 2003 |
| Received | May 27, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K031636
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2026 | Datascope Corp. CS100 IABP. Software Version CS100 IABP Q.01. Open, Classified |
DSP | None listed |
| Jul 17, 2017 | Maquet Datascope Corp - Cardiac Assist Division CS 100i Intra-Aortic Balloon Pump.
It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pr Open, Classified |
DSP | None listed |
| Jul 17, 2017 | Maquet Datascope Corp - Cardiac Assist Division CS 100 Intra-Aortic Balloon Pump.
It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pre Open, Classified |
DSP | None listed |
| Jun 23, 2017 | Maquet Datascope Corp - Cardiac Assist Division CS 100i Intra-Aortic Balloon Pump Terminated |
DSP | None listed |
| Jun 23, 2017 | Maquet Datascope Corp - Cardiac Assist Division CS 100 Intra-Aortic Balloon Pump Terminated |
DSP | None listed |
| May 21, 2014 | Maquet Datascope Corp - Cardiac Assist Division Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons Terminated |
DSP | None listed |
| Jun 13, 2011 | Maquet Datascope Corp - Cardiac Assist Division Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump;
Manufactured by Datascope Corp., 1300 MacArthur Blvd., M Terminated |
FMZ | None listed |
| Jun 21, 2010 | Datascope Corporation CS100 Intra-Aortic Balloon Pump. Terminated |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.