510(k) K901627 ยท DXE Catheter, Embolectomy
ARTERIAL EMBOLECTOMY CATHETER
| Applicant | Applied Vascular Devices, Inc., Laguna Hills CA, US |
| Decision | Substantially Equivalent, Oct 19, 1990 |
| Received | Apr 9, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901627
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2012 | Applied Medical Resources Corp Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX):
Model Numbers & Description:
A4402, 3F-40CM, SYNTEL RT-EMB;
A4403, 3F-80CM, SYNTEL RT-EMB;
A4404, 4F-40CM, SYNTEL RT-EMB;
A4405, 4F- Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.