510(k) K921638 ยท DSP System, Balloon, Intra-Aortic And Control
SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
| Applicant | Datascope Corp., Paramus NJ, US |
| Decision | Substantially Equivalent, Feb 10, 1993 |
| Received | Apr 6, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921638
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.