510(k) K911000 ยท DSP System, Balloon, Intra-Aortic And Control
PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON
| Applicant | Datascope Corp., Oakland NJ, US |
| Decision | Substantially Equivalent, Aug 25, 1993 |
| Received | Mar 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911000
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.