510(k) K892410 ยท DXE Catheter, Embolectomy
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
| Applicant | Baxter Healthcare Corp, Santa Ana CA, US |
| Decision | Substantially Equivalent, Jul 20, 1989 |
| Received | Apr 7, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892410
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2023 | Edwards Lifesciences, LLC Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 Open, Classified |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.