FDA.report

LEMAITRE VASCULAR, INC.

Matched from indexed company URL: Lemaitre Vascular, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
12209481220948LEMAITRE VASCULAR, INC.1N2026-01-0163 SECOND AVENUE BURLINGTON MA US 01803
22476861000121696LEMAITRE VASCULAR, INC.1N2026-01-01206 NORTH CENTER DR. N Brunswick NJ US 08902

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
304151241008255P020049PROCOL VASCULAR BIOPROSTHESISLXA2003-07-29
460181445411878N16837ARTEGRAFT{TM} AND REINFORCED ARTEGRAFT{TM}LXA1979-08-01
304151155557615K992368LEMAITRE EMBOLECTOMY CATHETERDXE1999-12-09
304151999542283K9807232.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)MGZ1999-02-12
304151285146023K973465LATIS GRAFT CLEANING CATHETERDXE1998-02-19
304152026015951K973334OZ POWER SYRINGEDXT1998-04-03
304151157571248K970762DUAL LUMEN EMBOLECTOMY CATHETERDXE1997-03-28
304151792081320K962043AUTO SUTURE MODIFIED VCS CLIP APPLIERFZP1996-09-23
304152062371922K960715PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8FMJN1996-09-09
304151828059157K951721APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPELYK1995-07-11
304151916257331K950813MOLLRING CUTTERDWX1995-07-25
304151145794003K950586AVD INTIMAX THROMBECTOMY CATHETERDXE1995-05-15
304151547751873K944858BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTSDSY1995-01-05
304151220164073K944844BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFTDYF1995-03-31
304151671372225K933887IMPLANTABLE CLIPFZP1993-11-24
304151371214727K933590BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFTDSY1994-01-26
304151379983299K932184STERILE LEMAITRE GLOW 'N TELL TAPEKFX1993-07-22
304151678788490K921922GRICE LAPAROSCOPIC SUTURING NEEDLEGCJ1992-07-08
304151837628667K915175REDDICK RETRACTORGAD1992-04-29
304151909419153K911181INTIMAX(TM) IRRIGATION CATHETERGCA1991-04-18
304151044991100K910493AVD INTIMAX CHOLANGIOGRAPHY CATHETERFGE1991-03-28
304151991565300K910372INTIMAX THROMBECTOMY CATHETERDXE1991-04-26
304151862081219K910006AVD INTIMAX (TM) BILIARY CATHETERFGE1991-02-13
304151480565382K902327EMBOLECTOMY CATHETERDXE1991-02-25
304151995952630K901627ARTERIAL EMBOLECTOMY CATHETERDXE1990-10-19
304151919845487K880231MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETERDQT1988-05-25
304152007929435K872090THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KITDQT1987-10-30
304151467258996K860743CAROTID BYPASS SHUNT WITH SAMPLING ARMDWF1986-05-28
304151520399132K860742CAROTID BYPASS SHUNTDWF1986-05-28
304151207374363K860258TELEFLEX TEFLON COATED GUIDEWIREDQX1986-05-20
304151810849659K844918OCCLUSION & OCCLUSION-IRRIGATIONDQT1985-08-05
304151930622245K821220MULTILUMEN INTRAVENOUS INFUSION CATHETERGBP1982-07-09
304151514423274K811276OCCLUSION CATHETERDYG1981-06-30
304151039176708K212894PhasTIPPDWQ2022-03-31
304151886707679K202049Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterDXE2021-09-07
304151614617102K190882XenoSure Biologic PatchPSQ2020-02-13
304151344805440K190267EZE SIT ValvulotomeMGZ2019-10-30
304152048338238K183513XenoSure Dura Biologic PatchGXQ2019-06-13
304151845074673K182916Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 FrMJN2018-11-16
304151595472193K173323AnastoClip GC Closure SystemFZP2018-03-08
304151105792017K162579VascuCelDXZ2016-10-14
304151236706634K152833Pruitt F3-S Polyurethane Carotid ShuntMJN2016-01-21
304151995651090K143454Pruitt F3-S Carotid ShuntMJN2015-08-27
304151396473467K142660Antegrade LeMills ValvulotomeMGZ2014-10-17
304151307260398K1400421.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOMEMGZ2014-04-10
304151266640052K133026UNBALLOON NON-OCCLUSION MODELING CATHETERDQY2013-12-31
304151293656369K132190EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOMEMGZ2013-08-05
304151068265664K132047LEMILLS VALVULOTOMEMGZ2013-11-05
304151031635193K132022LEMAITRE 8F OCCLUSION CATHETERMJN2013-11-06
304152072399051K130872CARDIOCELDXZ2014-01-30
304151188811295K130016LIFESPAN EPTFE VASCULAR GRAFTDSY2013-02-05
304151188811295K130016LIFESPAN EPTFE VASCULAR GRAFTDSY2013-02-05
304151467228595K121839UNBALLOON NON-OCCLUSIVE MODELING CATHETERDQY2012-08-08
304151828592733K121415MOLLRING MULTITASCDWX2012-09-05
304151481815515K120644MERIT HYDROPHILIC GUIDE WIREDQX2012-09-19
304151259911552K111884OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOMEMGZ2011-07-29
304151155524343K110891THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETERDQY2011-09-13
304151475019495K103356PRUITT CAROTID KITMJN2010-12-08
304152070569361K103080ALBOGRAFT VASCULAR PROSTHESISMAL2011-01-19
304151031554418K101740ALBOSURE POLYESTER VASCULAR PATCHDXZ2010-09-20
304152048325696K093231ALBOGRAFT VASCULAR PROSTHESISMAL2010-01-14
304152048325696K093231ALBOGRAFT VASCULAR PROSTHESISMAL2010-01-14
304151692799862K091987ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIPFZP2010-04-23
304151112196328K071367FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05MJN2007-08-29
304151514581089K051067PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)MJN2005-05-27
304151319568979K043023PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49MJN2004-12-03
304151101077289K040835PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16FTM2004-06-15
304151842589998K040223POLYVAC INSTRUMENT DELIVERY SYSTEMKCT2004-10-22
304151446663228K032900LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTSDSY2003-12-04
304151634371803K032387TRIVEX SYSTEMDWQ2003-10-29
304151493458747K032105ENDOHELIX ENDARTERECTOMY DEVICEDWX2003-10-30
304151646504051K032105ENDOHELIX ENDARTERECTOMY DEVICEDWX2003-10-30
304151416981724K032041DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)DWF2003-08-27
304151879881433K031948PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16DXZ2003-09-16
304152065888210K023688LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPERGAF2003-01-30
304151998224761K022145OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302DXE2003-01-14
304151918173264K003719VASCULAR ARCHITECTS PERISCOPE DEVICEDWX2001-02-28
3041511769431061969-12-31
3041511769431061969-12-31
3041511769431061969-12-31
3041511769431061969-12-31
3041513391867711969-12-31
3041513391867711969-12-31
3041513391867711969-12-31
3041513391867711969-12-31
3041516491385051969-12-31
3041516491385051969-12-31
3041516491385051969-12-31
3041516491385051969-12-31
3041519316953681969-12-31
3041519316953681969-12-31
3041519316953681969-12-31
3041519316953681969-12-31
3041519983924371969-12-31
3041519983924371969-12-31
3041519983924371969-12-31
3041519983924371969-12-31
304151406668146

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DXE92021-09-07
MJN92018-11-16
MGZ72019-10-30
DSY52013-02-05
DWX52012-09-05
FZP42018-03-08
DXZ42016-10-14
DQY32013-12-31
MAL32011-01-19
DWF32003-08-27
DQT31988-05-25
DWQ22022-03-31
DQX22012-09-19
LXA22003-07-29
FGE21991-03-28
PSQ12020-02-13
GXQ12019-06-13
KCT12004-10-22
FTM12004-06-15
GAF12003-01-30
DXT11998-04-03
LYK11995-07-11
DYF11995-03-31
KFX11993-07-22
GCJ11992-07-08
GAD11992-04-29
GCA11991-04-18
GBP11982-07-09
DYG11981-06-30

PMA

Artegraft Collagen Vascular Graft

2023-01-25

LeMaitre Vascular, Inc.63 Second Avenueburlington, MA 01803 PMA NumberN16837 Supplement NumberS029 Date Received12/30/2022 Decision Date01/25/2023 Product Code LXA  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

Artegraft Collagen Vascular Graft

2022-10-14

LeMaitre Vascular, Inc.63 Second Avenueburlington, MA 01803 PMA NumberN16837 Supplement NumberS028 Date Received09/16/2022 Decision Date10/14/2022 Product Code LXA  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

PMN

Applications

GUDID

YES Tape

2021-06-18

Lemaitre Vascular, Inc.