510(k) K965236 ยท DSP System, Balloon, Intra-Aortic And Control
SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
| Applicant | Datascope Corp., Paramus NJ, US |
| Decision | Substantially Equivalent, Jul 1, 1997 |
| Received | Dec 31, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965236
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.