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

FDA 510(k) cleared devices by LeMaitre Vascular, Inc. Cardiovascular

25 devices
1-25 of 25
Cleared Mar 31, 2022
PhasTIPP
K212894 · DWQ
Cardiovascular · 202d
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
Cleared Dec 14, 2012
UNBALLOON NON-OCCLUSIVE MODELING CATHETER
K123531 · DQY
Cardiovascular · 28d
Cleared Sep 05, 2012
MOLLRING MULTITASC
K121415 · DWX
Cardiovascular · 117d
Cleared Aug 08, 2012
UNBALLOON NON-OCCLUSIVE MODELING CATHETER
K121839 · DQY
Cardiovascular · 47d
Cleared Sep 13, 2011
THE UNBALLOON NON-OCCLUSIVE CATHETER
K110891 · DQY
Cardiovascular · 167d
Cleared Jul 29, 2011
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
K111884 · MGZ
Cardiovascular · 28d
Cleared Jan 19, 2011
ALBOGRAFT VASCULAR PROSTHESIS
K103080 · MAL
Cardiovascular · 92d
Cleared Sep 20, 2010
ALBOSURE POLYESTER VASCULAR PATCH
K101740 · DXZ
Cardiovascular · 91d
Cleared Jan 14, 2010
ALBOGRAFT VASCULAR PROSTHESIS
K093231 · MAL
Cardiovascular · 92d
Cleared Jan 27, 2009
LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
K081878 · DQY
Cardiovascular · 209d
Cleared Aug 29, 2007
FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
K071367 · MJN
Cardiovascular · 105d
Cleared May 27, 2005
PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
K051067 · MJN
Cardiovascular · 31d
Cleared Dec 03, 2004
PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49,...
K043023 · MJN
Cardiovascular · 30d
Cleared Dec 19, 2003
LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01,...
K033159 · MJN
Cardiovascular · 80d
Cleared Aug 27, 2003
DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
K032041 · DWF
Cardiovascular · 57d
Cleared Jan 14, 2003
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
K022145 · DXE
Cardiovascular · 196d
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