510(k) K963187 ยท DSP System, Balloon, Intra-Aortic And Control
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Nov 4, 1996 |
| Received | Aug 14, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963187
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.