510(k) K831397 ยท DSP System, Balloon, Intra-Aortic And Control
FRENCH INTRA-AORTIC 9.5 BALLOON ON KON
| Applicant | Datascope Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 2, 1983 |
| Received | Apr 29, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831397
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.