Medical Device Manufacturer · US , Burlington , MA

LeMaitre Vascular, Inc. - FDA 510(k) Cleared Devices

32 submissions · 32 cleared · Since 2003
32
Total
32
Cleared
0
Denied

LeMaitre Vascular, Inc. has 32 FDA 510(k) cleared cardiovascular devices. Based in Burlington, US.

Last cleared in 2022. Active since 2003.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - LeMaitre Vascular, Inc.
32 devices
1-12 of 32
Cleared Mar 31, 2022
PhasTIPP
K212894 · DWQ
Cardiovascular · 202d
Cleared Jun 13, 2019
XenoSure Dura Biologic Patch
K183513 · GXQ
Neurology · 177d
Cleared Mar 08, 2018
AnastoClip GC Closure System
K173323 · FZP
General & Plastic Surgery · 139d
Cleared Jan 21, 2016
Pruitt F3-S Polyurethane Carotid Shunt
K152833 · MJN
Cardiovascular · 114d
Cleared Aug 27, 2015
Pruitt F3-S Carotid Shunt
K143454 · MJN
Cardiovascular · 267d
Cleared Oct 17, 2014
Antegrade LeMills Valvulotome
K142660 · MGZ
Cardiovascular · 29d
Cleared Apr 10, 2014
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
K140042 · MGZ
Cardiovascular · 92d
Cleared Dec 31, 2013
UNBALLOON NON-OCCLUSION MODELING CATHETER
K133026 · DQY
Cardiovascular · 96d
Cleared Nov 06, 2013
LEMAITRE 8F OCCLUSION CATHETER
K132022 · MJN
Cardiovascular · 128d
Cleared Nov 05, 2013
LEMILLS VALVULOTOME
K132047 · MGZ
Cardiovascular · 126d
Cleared Aug 05, 2013
EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME
K132190 · MGZ
Cardiovascular · 21d
Cleared Feb 05, 2013
LIFESPAN EPTFE VASCULAR GRAFT
K130016 · DSY
Cardiovascular · 35d
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All32 Cardiovascular 25 General & Plastic Surgery 4 General Hospital 2 Neurology 1