510(k) K901625 ยท DXE Catheter, Embolectomy
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
| Applicant | Baxter Healthcare Corp, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 6, 1990 |
| Received | Apr 9, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901625
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2017 | Edwards Lifesciences, LLC Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806
Product Usage:
The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. T Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.