510(k) K961509 ยท DSP System, Balloon, Intra-Aortic And Control
INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
| Applicant | Datascope Corp., Paramus NJ, US |
| Decision | Substantially Equivalent, Nov 15, 1996 |
| Received | Apr 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961509
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.