510(k) K945230 ยท DSP System, Balloon, Intra-Aortic And Control
ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, May 9, 1995 |
| Received | Oct 26, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945230
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.