Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1220948

FEI Number

1220948

Entity Name

LEMAITRE VASCULAR, INC.

City/State/Country

BURLINGTON, MA, US

Establishment Address

63 SECOND AVENUE, BURLINGTON, MA 01803, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LEMAITRE VASCULAR, INC. (Owner Number: 1220948)

Owner / Operator Contact Address

32 Third Ave, --, Burlington, MA 01803, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K932184

PMA Number

N/A

All Registered Proprietary Names

Python OTW Embolectomy Catheter AnastoClip GC Closure System XenoSure PRUITT BALLOON OCCLUSION CATHETER Syntel OTW Embolectomy Catheter XenoSure Biologic Patch Novasil Catheter Single Lumen Catheter Pruitt Aortic Occlusion Catheter Over-the-Wire Valvulotome (OTW-ELV) LeMills Valvulotome HYDRO LeMaitre Valvulotome OVER-THE-WIRE EMBOLECTOMY CATHETER AnastoClip AC Closure System Flexcel Shunt VascuCel Vascular Patch DISTAL PERFUSION CATHETER Albograft Vascular Grafts Pruitt F3 Shunt F3 carotid shunts Pruitt Irrigation Catheter PhasTIPP AnastoClip Atraumatic Forceps Thrombectomy Catheter CardioCel Cardiovascular Patch Lifespan ePTFE Vascular Grafts VascuTape

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2019-01-24
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-10-16
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	2019-10-16
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2009-09-01
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2006-04-25
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2021-09-15
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2021-09-15
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2022-05-03
MFX	Vessel Guard Or Cover, To Facilitate Revision Surgeries	Cardiovascular	Class 2	870.3470	2022-05-03
PSQ	Intracardiac Patch Or Pledget, Biologically Derived	Cardiovascular	Class 2	870.3470	2022-05-03
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2001-04-25
DQT	Occluder, Catheter Tip	Cardiovascular	Class 2	870.1370	2011-10-17
MGZ	Valvulotome	Cardiovascular	Class 2	870.4885	2011-08-16
MGZ	Valvulotome	Cardiovascular	Class 2	870.4885	2013-11-18
MGZ	Valvulotome	Cardiovascular	Class 2	870.4885	2014-04-29
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2001-04-25
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2008-01-24
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	2008-01-24
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2011-10-17
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2023-03-06
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2005-08-24
MAL	Graft, Vascular, Synthetic/Biologic Composite	Cardiovascular	Class 2	870.3450	2010-01-28
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2011-10-17
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2022-05-03
DQT	Occluder, Catheter Tip	Cardiovascular	Class 2	870.1370	2006-04-25
DWQ	Stripper, Vein, External	Cardiovascular	Class 2	870.4885	2022-04-28
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2004-09-22
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2019-01-24
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2023-03-06
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2013-08-09
KFX	Assembly, Thigh/Knee/Shank/Ankle/Foot, External	Physical Medicine	Class 2	890.3500	2001-04-25

Official Correspondent

Xiang Zhang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LEMAITRE VASCULAR, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31
K833836	Instrumentation Laboratory CO	IL HEPARINIZED FLOW DIRECTED THERMAL	1984-02-04
K792141	Pharmaseal Div., Baxter Healthcare Corp.	CONTINUOUS FLUSH DEVICE	1979-12-05
K924661	Baxter Healthcare Corp	SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER	1993-04-08
K051067	LeMaitre Vascular, Inc.	PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)	2005-05-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0031-05	N/A	1	Hem-o-lok Endo5 Ligation Applier
Z-0039-2020	AZIYO BIOLOGICS	2	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020	AZIYO BIOLOGICS	2	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
Z-0013-2009	Edwards Lifesciences, LLC	2	Edwards Lifesciences*Fogarty Fortis*Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1220948. Last updated year: 2026. Please use registration number 1220948 when referencing this establishment in official correspondence.