BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CORVASCULAR

    Reg #: 3033275035 · FEI: 3033275035 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    CORVASCULAR
    Registration Number
    3033275035
    FEI Number
    3033275035
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    5810 Baker Rd Ste 125
    City
    Minnetonka
    State
    MN
    ZIP
    55345
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121689

    Owner / Operator

    Firm Name
    Corvascular Diagnostics, LLC
    Operator Number
    10048428
    Address
    5810 Baker Road, Suite 125
    City
    Minnetonka
    State
    MN
    Postal Code
    55345
    Country
    US
    Correspondent
    Spencer Lien

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    Transducer, Ultrasonic JOP
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    Vitascan VasoGuard ASUS Ultrasound Imaging System (Model: LU800 series)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device