510(k) K002256 ยท DSP System, Balloon, Intra-Aortic And Control
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
| Applicant | Arrow Intl., Inc., Everett MA, US |
| Decision | Substantially Equivalent, May 3, 2001 |
| Received | Jul 25, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002256
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.