510(k) K943919 ยท DSP System, Balloon, Intra-Aortic And Control
9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER
| Applicant | Boston Scientific Corp, Watertown MA, US |
| Decision | Substantially Equivalent, Mar 23, 1995 |
| Received | Aug 12, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943919
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.