510(k) K963865 ยท DSP System, Balloon, Intra-Aortic And Control
8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Sep 16, 1997 |
| Received | Sep 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963865
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.