510(k) K942454 ยท DSP System, Balloon, Intra-Aortic And Control
DATASCOPE 95 AND 97 IAB PUMP CONSOLE
| Applicant | Datascope Corp., Oakland NJ, US |
| Decision | Substantially Equivalent, Feb 24, 1995 |
| Received | May 23, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942454
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.