510(k) K963104 ยท DSP System, Balloon, Intra-Aortic And Control
9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Feb 4, 1997 |
| Received | Aug 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963104
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.