510(k) K910372 ยท DXE Catheter, Embolectomy
INTIMAX THROMBECTOMY CATHETER
| Applicant | Applied Vascular Devices, Inc., Laguna Hills CA, US |
| Decision | Substantially Equivalent, Apr 26, 1991 |
| Received | Jan 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910372
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2024 | LeMaitre Vascular, Inc. Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies. Open, Classified |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.