510(k) K190101 ยท DSP System, Balloon, Intra-Aortic And Control
UltraFlex IAB
| Applicant | Arrow International, Inc., Chelmsford MA, US |
| Decision | Substantially Equivalent, Jun 28, 2019 |
| Received | Jan 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190101
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2024 | ARROW INTERNATIONAL Inc. Arrow UltraFlex Intra-Aortic Balloon Catheter Kit,
a) REF IAB-06830-U;
b) REF IAB-06840-U;
c) REF IAB-06850-U Open, Classified |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.