510(k) K935184 ยท DSP System, Balloon, Intra-Aortic And Control
REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING
| Applicant | St. Jude Medical, Inc., Chelmsford MA, US |
| Decision | Substantially Equivalent, Feb 10, 1995 |
| Received | Oct 26, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935184
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.