510(k) K192238 ยท DSP System, Balloon, Intra-Aortic And Control
AC3 Series Intra-Aortic Balloon Pump (IABP)
| Applicant | Arrow International, Teleflex, Chelmsford MA, US |
| Decision | Substantially Equivalent, Nov 12, 2019 |
| Received | Aug 19, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192238
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.