BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vensure™ Nav Balloon Dilation System

    Reg #: 3007225047 · FEI: 3007225047 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HEMOSTASIS, LLC
    Registration Number
    3007225047
    FEI Number
    3007225047
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5000 Township Pkwy
    City
    Saint Paul
    State
    MN
    ZIP
    55110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230065

    Owner / Operator

    Firm Name
    Hemostasis, LLC
    Operator Number
    10023101
    Address
    5000 Township Parkway
    City
    Saint Paul
    State
    MN
    Postal Code
    55110
    Country
    US

    Products

    Device Name Product Code
    Instrument, Ent Manual Surgical LRC
    Eustachian Tube Balloon Dilation Device PNZ

    Proprietary Names

    Vensure™ Nav Balloon Dilation System Vensure ™ Balloon Dilation System Vensure™ Light Balloon Dilation System Vensure™ ET Balloon Dilation

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)