510(k) K200634 ยท DSP System, Balloon, Intra-Aortic And Control
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
| Applicant | Arrow International, Inc., Chelmsford MA, US |
| Decision | Substantially Equivalent, Apr 9, 2020 |
| Received | Mar 10, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200634
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2024 | ARROW INTERNATIONAL Inc. Arrow FiberOptix Intra-Aortic Balloon Catheter Kit:
a) REF IAB-05830-LWS;
b) REF IAB-05840-LWS;
c) REF IAB-05850-LWS Open, Classified |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.