510(k) K961358 ยท DSP System, Balloon, Intra-Aortic And Control
ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Jul 2, 1996 |
| Received | Apr 8, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961358
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.