510(k) K954431 ยท DSP System, Balloon, Intra-Aortic And Control
PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Jan 11, 1996 |
| Received | Sep 25, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954431
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.