510(k) K972113 ยท DSP System, Balloon, Intra-Aortic And Control
30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Sep 2, 1997 |
| Received | Jun 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972113
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.