510(k) K232343 · DSP System, Balloon, Intra-Aortic And Control
AC3 Series IABP
| Applicant | Arrow International, LLC, Morrisville NC, US |
| Decision | Substantially Equivalent, Aug 30, 2023 |
| Received | Aug 4, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K232343
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.