510(k) K963920 ยท DSP System, Balloon, Intra-Aortic And Control
8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Jun 17, 1997 |
| Received | Sep 30, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963920
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.