510(k) K970762 ยท DXE Catheter, Embolectomy
DUAL LUMEN EMBOLECTOMY CATHETER
| Applicant | Applied Medical Resources, Launa Hills CA, US |
| Decision | Substantially Equivalent, Mar 28, 1997 |
| Received | Mar 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970762
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2020 | Applied Medical Resources Corp Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI:
A4E01/(01)00607915113407;
A4E02/(01)00607915113414;
A4E03/(01)00607915113421;
A4E04/(01)00607915113438;
A4E05/(01)00607915113445;
A4 Terminated |
DXE | None listed |
| May 7, 2020 | Applied Medical Resources Corp Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI:
CE0340DR/(01)H699CE0340DR10R;
CE0380DR/(01)H699CE0380DR10V;
CE0440DR/(01)H699CE0440DR10S;
CE0480DR/(01)H699CE0480DR10W;
CE0540DR/(01)H69 Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.