BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LEMAITRE VASCULAR, INC.

    Reg #: 1220948 · FEI: 1220948 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    19

    Registration Details

    Registration Name
    LEMAITRE VASCULAR, INC.
    Registration Number
    1220948
    FEI Number
    1220948
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    63 SECOND AVENUE
    City
    BURLINGTON
    State
    MA
    ZIP
    01803
    Country
    US

    Regulatory Submissions

    510(k) Number
    K970762

    Owner / Operator

    Firm Name
    LEMAITRE VASCULAR, INC.
    Operator Number
    1220948
    Address
    32 Third Ave, --
    City
    Burlington
    State
    MA
    Postal Code
    01803
    Country
    US
    Correspondent
    Xiang Zhang

    Products

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

    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 AnastoClip GC (GripClip) DuraSure Biologic Patch EZE-SIT Valvulotome Pruitt F3-S Polyurethane Carotid Shunt

    Establishment Types

    Manufacture Medical Device