510(k) K944460 ยท DSP System, Balloon, Intra-Aortic And Control
DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD
| Applicant | Datascope Corp., Fairfield NJ, US |
| Decision | Substantially Equivalent, Dec 9, 1994 |
| Received | Sep 12, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944460
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.