LEMAITRE EMBOLECTOMY CATHETER— 510(k) K992368

Name: FDA 510(k) clearance K992368
Creator: U.S. Food and Drug Administration
Published: 1999-12-09

Substantially Equivalent

Vascutech, Inc.

FDA 510(k) clearance K992368 for LEMAITRE EMBOLECTOMY CATHETER, Substantially Equivalent on 1999-12-09. Applicant: Vascutech, Inc.. Device class: 2.

Clearance details

Applicant: Vascutech, Inc.
Product code: Code DXE
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 1999-07-15
Decision date: 1999-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXE

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K240078 — Fogarty Thru-Lumen Embolectomy Catheter2024-08-28
K241330 — Fogarty Fortis Arterial Embolectomy Catheter2024-07-02
K233819 — Fogarty Venous Thrombectomy Catheters2024-05-22
K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve2024-05-22
K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters2024-05-20

More clearances from Vascutech, Inc.

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K001621 — DARDIK CAROTID SHUNT2000-12-06
K992942 — LEMAITRE OCCLUSION CATHETER2000-04-13
K992933 — LEMAITRE IRRIGATION CATHETER2000-03-08
K992934 — LEMAITRE VENOUS THROMBECTOMY CATHETER2000-03-01
K992940 — LEMAITRE BALLOON CATHETER WITH IRRIGATION2000-02-22

Adverse events under product code DXE

product code DXE

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 →

Recalls naming K992368

K-number listed on FDA's recall record

Z-0228-2023 — TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..Class II·Ongoing·LeMaitre Vascular, Inc.·20220930
Z-0386-2016 — LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.Class II·Terminated·LeMaitre Vascular, Inc.·20151021
Z-0387-2016 — LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.Class II·Terminated·LeMaitre Vascular, Inc.·20151021
Z-0388-2016 — LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.Class II·Terminated·LeMaitre Vascular, Inc.·20151021
Z-0389-2016 — LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.Class II·Terminated·LeMaitre Vascular, Inc.·20151021
Z-0390-2016 — LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. 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 K992368.

Data sourced from openFDA. This site is unofficial and independent of the FDA.