BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VasoGuard (V10, V8, V6, V4, V2)

    K Number: K233976 · Decision Jul 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    71
    Applicant Total
    1
    Review Days
    217

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    Basic Information

    Device Name
    VasoGuard (V10, V8, V6, V4, V2)
    K Number
    K233976
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2880
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Corvascular Diagnostics, LLC
    Date Received
    December 15, 2023
    Decision Date
    July 19, 2024
    Product Code
    JOP
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOP Transducer, Ultrasonic

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