Data / Medical devices / United States / LeMaitre Vascular Inc.

LeMaitre Vascular Inc.: FDA-registered device maker in Billerica, MA, United States, 29 510(k) clearances

Name: LeMaitre Vascular Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

LeMaitre Vascular Inc. is registered with the FDA (registration 3045042524) in Billerica, MA, United States. It lists 19 device types. The FDA files 29 510(k) clearances under its listings, the newest dated March 31, 2022. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3045042524
Address: 47 Dunham Rd, Billerica, MA, United States, 01821
Owner or operator: LEMAITRE VASCULAR, INC. (1220948)
Roles: Manufacturer
First device listed: April 25, 2001
Registered through: 2027
Brand names listed: Albograft Vascular Grafts, AnastoClip AC Closure System, AnastoClip Atraumatic Forceps, AnastoClip GC (GripClip), AnastoClip GC Closure System, CardioCel Cardiovascular Patch, DISTAL PERFUSION CATHETER, DuraSure Biologic Patch and more

Devices it lists

Device	Product code	Class	Role	Source
Applier, Hemostatic Clip	HBT	1	Manufacturer	accessdata.fda.gov
Assembly, Thigh/Knee/Shank/Ankle/Foot, External	KFX	2	Manufacturer	accessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	DWF	2	Manufacturer	accessdata.fda.gov
Catheter, Continuous Flush	KRA	2	Manufacturer	accessdata.fda.gov
Catheter, Embolectomy	DXE	2	Manufacturer	accessdata.fda.gov
Catheter, Flow Directed	DYG	2	Manufacturer	accessdata.fda.gov
Catheter, Intravascular Occluding, Temporary	MJN	2	Manufacturer	accessdata.fda.gov
Clip, Implantable	FZP	2	Manufacturer	accessdata.fda.gov
Dura Substitute	GXQ	2	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Graft, Vascular, Synthetic/Biologic Composite	MAL	2	Manufacturer	accessdata.fda.gov
Intracardiac Patch Or Pledget, Biologically Derived	PSQ	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical	FTM	2	Manufacturer	accessdata.fda.gov
Occluder, Catheter Tip	DQT	2	Manufacturer	accessdata.fda.gov
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	DXZ	2	Manufacturer	accessdata.fda.gov
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	DSY	2	Manufacturer	accessdata.fda.gov
Stripper, Vein, External	DWQ	2	Manufacturer	accessdata.fda.gov
Valvulotome	MGZ	2	Manufacturer	accessdata.fda.gov
Vessel Guard Or Cover, To Facilitate Revision Surgeries	MFX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 31, 2022	K212894	PhasTIPP	DWQ	Substantially Equivalent	LeMaitre Vascular, Inc.	accessdata.fda.gov
September 7, 2021	K202049	Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter	DXE	Substantially Equivalent	Applied Medical Resources Corporation	accessdata.fda.gov
February 13, 2020	K190882	XenoSure Biologic Patch	PSQ	Substantially Equivalent	Lemaitre Vascular	accessdata.fda.gov
October 30, 2019	K190267	EZE SIT Valvulotome	MGZ	Substantially Equivalent	Lemaitre Vascular	accessdata.fda.gov
June 13, 2019	K183513	XenoSure Dura Biologic Patch	GXQ	Substantially Equivalent	LeMaitre Vascular, Inc.	accessdata.fda.gov
November 16, 2018	K182916	Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr	MJN	Substantially Equivalent	Lemaitre Vascular	accessdata.fda.gov
March 8, 2018	K173323	AnastoClip GC Closure System	FZP	Substantially Equivalent	LeMaitre Vascular, Inc.	accessdata.fda.gov
October 14, 2016	K162579	VascuCel	DXZ	Substantially Equivalent	Admedus Regen Pty, Ltd.	accessdata.fda.gov
January 21, 2016	K152833	Pruitt F3-S Polyurethane Carotid Shunt	MJN	Substantially Equivalent	LeMaitre Vascular, Inc.	accessdata.fda.gov
April 10, 2014	K140042	1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME	MGZ	Substantially Equivalent	LeMaitre Vascular, Inc.	accessdata.fda.gov
January 30, 2014	K130872	CARDIOCEL	DXZ	Substantially Equivalent	Celxcel Pty, Ltd.	accessdata.fda.gov
November 5, 2013	K132047	LEMILLS VALVULOTOME	MGZ	Substantially Equivalent	LeMaitre Vascular, Inc.	accessdata.fda.gov
February 5, 2013	K130016	LIFESPAN EPTFE VASCULAR GRAFT	DSY	Substantially Equivalent	LeMaitre Vascular, Inc.	accessdata.fda.gov
July 29, 2011	K111884	OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME	MGZ	Substantially Equivalent	LeMaitre Vascular, Inc.	accessdata.fda.gov
April 23, 2010	K091987	ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP	FZP	Substantially Equivalent	LeMaitre Vascular, Inc.	accessdata.fda.gov
January 14, 2010	K093231	ALBOGRAFT VASCULAR PROSTHESIS	MAL	Substantially Equivalent	LeMaitre Vascular, Inc.	accessdata.fda.gov
August 29, 2007	K071367	FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05	MJN	Substantially Equivalent	LeMaitre Vascular, Inc.	accessdata.fda.gov
May 27, 2005	K051067	PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)	MJN	Substantially Equivalent	LeMaitre Vascular, Inc.	accessdata.fda.gov
June 15, 2004	K040835	PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16	FTM	Substantially Equivalent	Pm Devices, Inc.	accessdata.fda.gov
August 27, 2003	K032041	DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)	DWF	Substantially Equivalent	LeMaitre Vascular, Inc.	accessdata.fda.gov
January 14, 2003	K022145	OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302	DXE	Substantially Equivalent	LeMaitre Vascular, Inc.	accessdata.fda.gov
December 9, 1999	K992368	LEMAITRE EMBOLECTOMY CATHETER	DXE	Substantially Equivalent	Vascutech, Inc.	accessdata.fda.gov
March 28, 1997	K970762	DUAL LUMEN EMBOLECTOMY CATHETER	DXE	Substantially Equivalent	Applied Medical Resources	accessdata.fda.gov
September 23, 1996	K962043	AUTO SUTURE MODIFIED VCS CLIP APPLIER	FZP	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
July 22, 1993	K932184	STERILE LEMAITRE GLOW 'N TELL TAPE	KFX	Substantially Equivalent	Vascutech, Inc.	accessdata.fda.gov
April 26, 1991	K910372	INTIMAX THROMBECTOMY CATHETER	DXE	Substantially Equivalent	Applied Vascular Devices, Inc.	accessdata.fda.gov
May 25, 1988	K880231	MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER	DQT	Substantially Equivalent	Ideas For Medicine, Inc.	accessdata.fda.gov
October 30, 1987	K872090	THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT	DQT	Substantially Equivalent	Ideas For Medicine, Inc.	accessdata.fda.gov
June 30, 1981	K811276	OCCLUSION CATHETER	DYG	Substantially Equivalent	Bionomy, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 31, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.