510(k) K993966 ยท DSP System, Balloon, Intra-Aortic And Control
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
| Applicant | Arrow Intl., Inc., Everett MA, US |
| Decision | Substantially Equivalent, Feb 18, 2000 |
| Received | Nov 23, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K993966
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2024 | ARROW INTERNATIONAL Inc. Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit,
a) REF IAB-05830-U;
b) REF IAB-05840-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.