510(k) K193379 ยท DXE Catheter, Embolectomy
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 12, 2020 |
| Received | Dec 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193379
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2022 | Edwards Lifesciences, LLC Fogarty Arterial Embolectomy Catheters Model Number:
120602FP
120403FP
120803FP
120404FP
120804FP
120805FP
120806FP
120807FP
Fogarty Arterial Embolectomy Catheter with Stylet Model Number:
120403FSP Open, Classified |
DXE | None listed |
| Oct 28, 2022 | Edwards Lifesciences, LLC Fogarty Biliary Balloon Probes Model Number:
410235FP
410405FP
410236FP Open, Classified |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.