BEUDAMED
    FDA Registration Inactive 🇺🇸 United States

    LeMaitre Vascular Inc.

    · Expires 2026
    Products
    19
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    19

    Registration Details

    Registration Name
    LeMaitre Vascular Inc.
    Status
    Inactive
    Expiry Year
    2026
    Initial Importer
    No
    Address
    47 Dunham Rd
    City
    Billerica
    State
    MA
    ZIP
    01821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K071367

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

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device