510(k) K821065 ยท DSP System, Balloon, Intra-Aortic And Control
DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL
| Applicant | Datascope Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 19, 1982 |
| Received | Apr 15, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821065
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.