510(k) K974247 ยท DSP System, Balloon, Intra-Aortic And Control
40 CC GRANDE
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Feb 10, 1998 |
| Received | Nov 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974247
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.