510(k) K896497 ยท DSP System, Balloon, Intra-Aortic And Control
PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON
| Applicant | Datascope Corp., Oakland NJ, US |
| Decision | Substantially Equivalent, Aug 17, 1990 |
| Received | Nov 14, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896497
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.