BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OutFlo Aortic Valve Valvuloplasty Perfusion Dilatation Catheter

    Reg #: 3029663075 · FEI: 3029663075 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Medinotec Inc
    Registration Number
    3029663075
    FEI Number
    3029663075
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    200 Broadhollow Road
    City
    Dix Hills
    State
    NY
    ZIP
    11747
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241562

    Owner / Operator

    Firm Name
    Medinotec Inc
    Operator Number
    10088772
    Address
    200 Broadhollow Rd
    City
    Melville
    State
    NY
    Postal Code
    11747
    Country
    US
    Correspondent
    Lyndon Oldfield

    Products

    Device Name Product Code
    Balloon Aortic Valvuloplasty OZT

    Proprietary Names

    OutFlo Aortic Valve Valvuloplasty Perfusion Dilatation Catheter

    Establishment Types

    Repack or Relabel Medical Device