LEMAITRE VASCULAR, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1220948	1220948	LEMAITRE VASCULAR, INC.	1	N	2026-01-01	63 SECOND AVENUE BURLINGTON MA US 01803
2247686	1000121696	LEMAITRE VASCULAR, INC.	1	N	2026-01-01	206 NORTH CENTER DR. N Brunswick NJ US 08902

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00840663102815	AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 15cmx6mm	781-221-2266	csus@lemaitre.com

lemaitre.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
30415	1241008255	P020049	PROCOL VASCULAR BIOPROSTHESIS	LXA	2003-07-29
46018	1445411878	N16837	ARTEGRAFT{TM} AND REINFORCED ARTEGRAFT{TM}	LXA	1979-08-01
30415	1155557615	K992368	LEMAITRE EMBOLECTOMY CATHETER	DXE	1999-12-09
30415	1999542283	K980723	2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)	MGZ	1999-02-12
30415	1285146023	K973465	LATIS GRAFT CLEANING CATHETER	DXE	1998-02-19
30415	2026015951	K973334	OZ POWER SYRINGE	DXT	1998-04-03
30415	1157571248	K970762	DUAL LUMEN EMBOLECTOMY CATHETER	DXE	1997-03-28
30415	1792081320	K962043	AUTO SUTURE MODIFIED VCS CLIP APPLIER	FZP	1996-09-23
30415	2062371922	K960715	PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F	MJN	1996-09-09
30415	1828059157	K951721	APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE	LYK	1995-07-11
30415	1916257331	K950813	MOLLRING CUTTER	DWX	1995-07-25
30415	1145794003	K950586	AVD INTIMAX THROMBECTOMY CATHETER	DXE	1995-05-15
30415	1547751873	K944858	BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS	DSY	1995-01-05
30415	1220164073	K944844	BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT	DYF	1995-03-31
30415	1671372225	K933887	IMPLANTABLE CLIP	FZP	1993-11-24
30415	1371214727	K933590	BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT	DSY	1994-01-26
30415	1379983299	K932184	STERILE LEMAITRE GLOW 'N TELL TAPE	KFX	1993-07-22
30415	1678788490	K921922	GRICE LAPAROSCOPIC SUTURING NEEDLE	GCJ	1992-07-08
30415	1837628667	K915175	REDDICK RETRACTOR	GAD	1992-04-29
30415	1909419153	K911181	INTIMAX(TM) IRRIGATION CATHETER	GCA	1991-04-18
30415	1044991100	K910493	AVD INTIMAX CHOLANGIOGRAPHY CATHETER	FGE	1991-03-28
30415	1991565300	K910372	INTIMAX THROMBECTOMY CATHETER	DXE	1991-04-26
30415	1862081219	K910006	AVD INTIMAX (TM) BILIARY CATHETER	FGE	1991-02-13
30415	1480565382	K902327	EMBOLECTOMY CATHETER	DXE	1991-02-25
30415	1995952630	K901627	ARTERIAL EMBOLECTOMY CATHETER	DXE	1990-10-19
30415	1919845487	K880231	MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER	DQT	1988-05-25
30415	2007929435	K872090	THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT	DQT	1987-10-30
30415	1467258996	K860743	CAROTID BYPASS SHUNT WITH SAMPLING ARM	DWF	1986-05-28
30415	1520399132	K860742	CAROTID BYPASS SHUNT	DWF	1986-05-28
30415	1207374363	K860258	TELEFLEX TEFLON COATED GUIDEWIRE	DQX	1986-05-20
30415	1810849659	K844918	OCCLUSION & OCCLUSION-IRRIGATION	DQT	1985-08-05
30415	1930622245	K821220	MULTILUMEN INTRAVENOUS INFUSION CATHETER	GBP	1982-07-09
30415	1514423274	K811276	OCCLUSION CATHETER	DYG	1981-06-30
30415	1039176708	K212894	PhasTIPP	DWQ	2022-03-31
30415	1886707679	K202049	Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter	DXE	2021-09-07
30415	1614617102	K190882	XenoSure Biologic Patch	PSQ	2020-02-13
30415	1344805440	K190267	EZE SIT Valvulotome	MGZ	2019-10-30
30415	2048338238	K183513	XenoSure Dura Biologic Patch	GXQ	2019-06-13
30415	1845074673	K182916	Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr	MJN	2018-11-16
30415	1595472193	K173323	AnastoClip GC Closure System	FZP	2018-03-08
30415	1105792017	K162579	VascuCel	DXZ	2016-10-14
30415	1236706634	K152833	Pruitt F3-S Polyurethane Carotid Shunt	MJN	2016-01-21
30415	1995651090	K143454	Pruitt F3-S Carotid Shunt	MJN	2015-08-27
30415	1396473467	K142660	Antegrade LeMills Valvulotome	MGZ	2014-10-17
30415	1307260398	K140042	1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME	MGZ	2014-04-10
30415	1266640052	K133026	UNBALLOON NON-OCCLUSION MODELING CATHETER	DQY	2013-12-31
30415	1293656369	K132190	EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME	MGZ	2013-08-05
30415	1068265664	K132047	LEMILLS VALVULOTOME	MGZ	2013-11-05
30415	1031635193	K132022	LEMAITRE 8F OCCLUSION CATHETER	MJN	2013-11-06
30415	2072399051	K130872	CARDIOCEL	DXZ	2014-01-30
30415	1188811295	K130016	LIFESPAN EPTFE VASCULAR GRAFT	DSY	2013-02-05
30415	1467228595	K121839	UNBALLOON NON-OCCLUSIVE MODELING CATHETER	DQY	2012-08-08
30415	1828592733	K121415	MOLLRING MULTITASC	DWX	2012-09-05
30415	1481815515	K120644	MERIT HYDROPHILIC GUIDE WIRE	DQX	2012-09-19
30415	1259911552	K111884	OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME	MGZ	2011-07-29
30415	1155524343	K110891	THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER	DQY	2011-09-13
30415	1475019495	K103356	PRUITT CAROTID KIT	MJN	2010-12-08
30415	2070569361	K103080	ALBOGRAFT VASCULAR PROSTHESIS	MAL	2011-01-19
30415	1031554418	K101740	ALBOSURE POLYESTER VASCULAR PATCH	DXZ	2010-09-20
30415	2048325696	K093231	ALBOGRAFT VASCULAR PROSTHESIS	MAL	2010-01-14
30415	1692799862	K091987	ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP	FZP	2010-04-23
30415	1112196328	K071367	FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05	MJN	2007-08-29
30415	1514581089	K051067	PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)	MJN	2005-05-27
30415	1319568979	K043023	PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49	MJN	2004-12-03
30415	1101077289	K040835	PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16	FTM	2004-06-15
30415	1842589998	K040223	POLYVAC INSTRUMENT DELIVERY SYSTEM	KCT	2004-10-22
30415	1446663228	K032900	LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS	DSY	2003-12-04
30415	1634371803	K032387	TRIVEX SYSTEM	DWQ	2003-10-29
30415	1493458747	K032105	ENDOHELIX ENDARTERECTOMY DEVICE	DWX	2003-10-30
30415	1646504051	K032105	ENDOHELIX ENDARTERECTOMY DEVICE	DWX	2003-10-30
30415	1416981724	K032041	DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)	DWF	2003-08-27
30415	1879881433	K031948	PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16	DXZ	2003-09-16
30415	2065888210	K023688	LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER	GAF	2003-01-30
30415	1998224761	K022145	OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302	DXE	2003-01-14
30415	1918173264	K003719	VASCULAR ARCHITECTS PERISCOPE DEVICE	DWX	2001-02-28
30415	1176943106
30415	1339186771
30415	1649138505
30415	1931695368
30415	1998392437
30415	1406668146

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DXE	9	2021-09-07
MJN	9	2018-11-16
MGZ	7	2019-10-30
DSY	5	2013-02-05
DWX	5	2012-09-05
FZP	4	2018-03-08
DXZ	4	2016-10-14
DQY	3	2013-12-31
MAL	3	2011-01-19
DWF	3	2003-08-27
DQT	3	1988-05-25
DWQ	2	2022-03-31
DQX	2	2012-09-19
LXA	2	2003-07-29
FGE	2	1991-03-28
PSQ	1	2020-02-13
GXQ	1	2019-06-13
KCT	1	2004-10-22
FTM	1	2004-06-15
GAF	1	2003-01-30
DXT	1	1998-04-03
LYK	1	1995-07-11
DYF	1	1995-03-31
KFX	1	1993-07-22
GCJ	1	1992-07-08
GAD	1	1992-04-29
GCA	1	1991-04-18
GBP	1	1982-07-09
DYG	1	1981-06-30

PMN#

AnastoClip GC Closure System
2018-03-08
LeMaitre Vascular, Inc.
Pruitt F3-S Polyurethane Carotid Shunt
2016-01-21
LEMAITRE VASCULAR, INC.
Antegrade LeMills Valvulotome
2014-10-17
LeMaitre Vascular, Inc.
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
2014-04-10
LEMAITRE VASCULAR, INC.
UNBALLOON NON-OCCLUSION MODELING CATHETER
2013-12-31
LEMAITRE VASCULAR, INC.
LEMAITRE 8F OCCLUSION CATHETER
2013-11-06
LEMAITRE VASCULAR, INC.
LEMILLS VALVULOTOME
2013-11-05
LEMAITRE VASCULAR, INC.
EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME
2013-08-05
LEMAITRE VASCULAR, INC.
LIFESPAN EPTFE VASCULAR GRAFT
2013-02-05
LEMAITRE VASCULAR, INC.
UNBALLOON NON-OCCLUSIVE MODELING CATHETER
2012-12-14
LEMAITRE VASCULAR, INC.
MOLLRING MULTITASC
2012-09-05
LEMAITRE VASCULAR, INC.
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
2011-07-29
LEMAITRE VASCULAR, INC.
ALBOGRAFT VASCULAR PROSTHESIS
2011-01-19
LEMAITRE VASCULAR, INC.
PRUITT CAROTID KIT
2010-12-08
LEMAITRE VASCULAR, INC.
ALBOSURE POLYESTER VASCULAR PATCH
2010-09-20
LEMAITRE VASCULAR, INC.
ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
2010-04-23
LEMAITRE VASCULAR, INC.
ALBOGRAFT VASCULAR PROSTHESIS
2010-01-14
LEMAITRE VASCULAR, INC.
LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
2009-01-27
LeMaitre Vascular, Inc.
FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
2007-08-29
LEMAITRE VASCULAR, INC.
PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
2005-05-27
LEMAITRE VASCULAR, INC.
PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49
2004-12-03
LEMAITRE VASCULAR, INC.
LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05
2003-12-19
LEMAITRE VASCULAR, INC.
DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
2003-08-27
LEMAITRE VASCULAR, INC.
LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
2003-01-30
LEMAITRE VASCULAR, INC.
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
2003-01-14
LEMAITRE VASCULAR, INC.

GUDID#

AlboGraft Polyester Vascular Graft - AlboGraft® Woven with Collagen 34mm x 60cm
Lemaitre Vascular, Inc.
2021-06-18
AlboGraft Polyester Vascular Graft - AlboGraft® Woven with Collagen 38mm x 60cm
Lemaitre Vascular, Inc.
2021-06-18
AlboGraft Polyester Vascular Graft - AlboGraft® Woven with Collagen Bifurcated 12mm x 6mm x 50cm
Lemaitre Vascular, Inc.
2021-06-18
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 15cmx6mm
Lemaitre Vascular, Inc.
2015-07-30
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 40cmx6mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 60cmx6mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 100cmx6mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 40cmx7mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 15cmx8mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 30cmx8mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 40cmx8mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 60cmx7mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 60cmx8mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 100cmx8mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 15cmx10mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 30cmx10mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 40cmx10mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 60cmx10mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 100cmx10mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 15cmx12mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 30cmx12mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 15cmx14mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 30cmx14mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 15cmx16mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 30cmx16mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 15cmx18mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 30cmx18mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 15cmx20mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AMC3020
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 15cmx22mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 30cmx22mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 15cmx24mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 40cmx12mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 30cmx24mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 12cmx7mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 14cmx7mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 14cmx8mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 16cmx8mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 16cmx9mm
Lemaitre Vascular, Inc.
2015-10-16
AlboGraft Polyester Vascular Graft - AlboGraft Polyester Vascular Graft 18cmx8mm
Lemaitre Vascular, Inc.
2015-10-16

200 records. Showing 1-40. Next