510(k) K250542 · DSP System, Balloon, Intra-Aortic And Control
AC3 Range Intra-Aortic Balloon Pump
| Applicant | Arrow International, LLC, Morrisville NC, US |
| Decision | Substantially Equivalent, Mar 26, 2025 |
| Received | Feb 24, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250542
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.