510(k) K905056 ยท DSP System, Balloon, Intra-Aortic And Control
PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT
| Applicant | Datascope Corp., Oakland NJ, US |
| Decision | Substantially Equivalent, Jun 11, 1991 |
| Received | Nov 8, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905056
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.