510(k) K970689 ยท DSP System, Balloon, Intra-Aortic And Control
IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Jun 4, 1998 |
| Received | Feb 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970689
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.