510(k) K162820 ยท DSP System, Balloon, Intra-Aortic And Control
AC3 Series IABP System
| Applicant | Arrow International, Inc., Chelmsford MA, US |
| Decision | Substantially Equivalent, Mar 31, 2017 |
| Received | Oct 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162820
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2020 | Arrow International Inc Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700 Terminated |
DSP | None listed |
| Jun 26, 2020 | Arrow International Inc Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701 Terminated |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.