510(k) K910997 ยท DSP System, Balloon, Intra-Aortic And Control
DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
| Applicant | Datascope Corp., Oakland NJ, US |
| Decision | Substantially Equivalent - Market after Inspection, Nov 5, 1991 |
| Received | Mar 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910997
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.