510(k) K190117 ยท DSP System, Balloon, Intra-Aortic And Control
Fiberoptix IAB
| Applicant | Arrow International, Inc., Chelmsford MA, US |
| Decision | Substantially Equivalent, Jun 13, 2019 |
| Received | Jan 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190117
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.