OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302— 510(k) K022145

Clearance details

Applicant

LeMaitre Vascular, Inc.

Product code

Code DXE

Device class

Class 2

Regulation

21 CFR 870.5150

Advisory panel

Cardiovascular

Date received

2002-07-02

Decision date

2003-01-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Burlington, MA, US

• K240078 — Fogarty Thru-Lumen Embolectomy Catheter2024-08-28
• K241330 — Fogarty Fortis Arterial Embolectomy Catheter2024-07-02
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• K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve2024-05-22
• K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters2024-05-20

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• K152833 — Pruitt F3-S Polyurethane Carotid Shunt2016-01-21
• K143454 — Pruitt F3-S Carotid Shunt2015-08-27

Death

27

Injury

258

Malfunction

2,266

Total

2,551

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1750-2025 — 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, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.Class II·Ongoing·LeMaitre Vascular, Inc.·20250411
• Z-1567-2020 — 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 thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.Class I·Ongoing·LeMaitre Vascular, Inc.·20200323
• Z-0378-2016 — LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.Class II·Terminated·LeMaitre Vascular, Inc.·20151021
• Z-0379-2016 — LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.Class II·Terminated·LeMaitre Vascular, Inc.·20151021
• Z-0380-2016 — LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.Class II·Terminated·LeMaitre Vascular, Inc.·20151021
• Z-0381-2016 — LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.Class II·Terminated·LeMaitre Vascular, Inc.·20151021
• Z-0382-2016 — LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.Class II·Terminated·LeMaitre Vascular, Inc.·20151021
• Z-0383-2016 — LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.Class II·Terminated·LeMaitre Vascular, Inc.·20151021
• Z-0384-2016 — LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.Class II·Terminated·LeMaitre Vascular, Inc.·20151021
• Z-0385-2016 — LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.Class II·Terminated·LeMaitre Vascular, Inc.·20151021

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022145.