510(k) K980780 ยท DSP System, Balloon, Intra-Aortic And Control
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
| Applicant | Datascope Corp., Fairfield NJ, US |
| Decision | Substantially Equivalent, May 29, 1998 |
| Received | Mar 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980780
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.