510(k) K960713 ยท DSP System, Balloon, Intra-Aortic And Control
8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH)
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, May 15, 1996 |
| Received | Feb 21, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960713
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.