510(k) K022145 ยท DXE Catheter, Embolectomy
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
| Applicant | LeMaitre Vascular, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Jan 14, 2003 |
| Received | Jul 2, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022145
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2026 | LeMaitre Vascular, Inc. TufTex Over-the-Wire Embolectomy Catheter;
Catalog Number: E1651-88; Open, Classified |
DXE | None listed |
| May 12, 2025 | LeMaitre Vascular, Inc. TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48,
1651-58, 1651-64, 1651-68, 1651-78,
1651-84, 1651-88, E1651-34, E1651-38,
E1651-44, E1651-48, E1651- Open, Classified |
DXE | None listed |
| Apr 1, 2020 | LeMaitre Vascular, Inc. LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88.
The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and Open, Classified |
DXE | None listed |
| Dec 4, 2015 | LeMaitre Vascular, Inc. LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi. Terminated |
DXE | None listed |
| Dec 4, 2015 | LeMaitre Vascular, Inc. LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38.
Indicated for the removal of arterial emboli and thrombi. Terminated |
DXE | None listed |
| Dec 4, 2015 | LeMaitre Vascular, Inc. LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi. Terminated |
DXE | None listed |
| Dec 4, 2015 | LeMaitre Vascular, Inc. LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi. Terminated |
DXE | None listed |
| Dec 4, 2015 | LeMaitre Vascular, Inc. LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi. Terminated |
DXE | None listed |
| Dec 4, 2015 | LeMaitre Vascular, Inc. LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi. Terminated |
DXE | None listed |
| Dec 4, 2015 | LeMaitre Vascular, Inc. LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64.
Indicated for the removal of arterial emboli and thrombi. Terminated |
DXE | None listed |
| Dec 4, 2015 | LeMaitre Vascular, Inc. LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68.
Indicated for the removal of arterial emboli and thrombi. Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.