BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medtronic Heart Valves Division

    Reg #: 2025587 · FEI: 2025587 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    91
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    Medtronic Heart Valves Division
    Registration Number
    2025587
    FEI Number
    2025587
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1851 EAST DEERE AVE.
    City
    Santa Ana
    State
    CA
    ZIP
    92705
    Country
    US

    Regulatory Submissions

    510(k) Number
    K052899
    PMA Number
    P130021

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Ring, Annuloplasty KRH
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT
    Wire, Guide, Catheter DQX
    Holder, Heart-Valve, Prosthesis DTJ
    Sizer, Heart-Valve, Prosthesis DTI
    Electrode, Pacemaker, Temporary LDF
    Replacement Heart-Valve DYE
    Heart-Valve, Non-Allograft Tissue LWR
    Pulmonic Valved Conduit MWH
    Pulmonary Valve Prosthesis Percutaneously Delivered NPV
    Heart-Valve, Mechanical LWQ
    Instruments, Surgical, Cardiovascular DWS

    Proprietary Names

    Simulus Flexible Annuloplasty Band CoreValve Evolut PRO System Medtronic CoreValve System CoreValve Evolut R System CoreValve Evolut PRO+ System Evolut FX+ System Medtronic Evolut FX System Profile 3D Annuloplasty Ring Stedi™ Extra Support Guidewire CG Future Band Simplici-T SimuPlus, SimuForm Confida Brecker Curve Guidewire Simulus Adjustable Annuloplasty Ring Open Pivot Handle TriAd Handle CG Future Handle Profile 3D Handle Enable Folding System Open Pivot Rotator Duran Ancore Handle Open Pivot Holder HEART-VALVE Contour 3D Handle Simulus Handle Threaded or Valve handle Avalus™ Valve Handle PROSTHESIS HOLDER Tri-Ad Adams Annuloplasty Ring Hancock II ULTRA Supra-X Aortic Sizers TriAd sizers Contour 3D sizers Mosaic Ultra Supra-X Aortic Sizers CG Future Sizers Hancock II Aortic and Mitral Obturators Simulus Sizers Avalus™ Sizers Open Pivot sizers Profile 3D Ring Sizers Mosaic Aortic and Mitral Obturators Freestyle Obturators Duran Ancore Sizers Mosaic Neo Streamline Temporary Pacing Leads CG Future Ring Mosaic ULTRA Mosaic Hancock M.O. Hancock Modified Orifice Hancock MO Avalus™ bioprosthesis Duran Ancore Band Duran Ancore Ring Hancock Bioprosthesis Contegra Simulus Adjustable Annuloplasty Band Simulus Flexible Annuloplasty Ring Pulmonary Valve Ensemble Simulus Semi-Rigid Annuloplasty Band Ring, Annuloplasty - Contour 3D Ring Simulus Semi-Rigid Annuloplasty Ring Posterior Annuloplasty Band Streamline Temporary Pacing Wire MHV ATS Open Pivot Aortic Valved Graft ATS Open Pivot Bi-leaflet Freestyle Harmony Transcatheter Pulmonary Valve System Hancock II Ultra Hancock II MITRAL COLLAR AND TIE Actuators Rotation Tool Kit AORTIC CUFF Universal Mounting Rail pinch on tool MEDIUM BLADE SET TOOL Lead Accessory Kit Adjustable Slitter Implant Tool Kit ATRIAL LIFT SYSTEM Accessory Port ATS Medical Thoracic Port System EXTRA LG BLADE SET TOOL INTERCOSTAL RETRACTOR SYSTEM SUTURE BELT LARGE BLADE SET TOOL STERILIZATION TRAY TOOL RETRACTOR RACK TOOL SMALL BLADE SET TOOL Mounting Rail Universal II Slitter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device