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

    INFLOW INTRAURETHRAL VALVE-PUMP

    K Number: DEN130044 · Decision Oct 14, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    354

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    Basic Information

    Device Name
    INFLOW INTRAURETHRAL VALVE-PUMP
    K Number
    DEN130044
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    876.5140
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Vesiflo, Inc.
    Date Received
    October 25, 2013
    Decision Date
    October 14, 2014
    Product Code
    PIH
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PIH Urethral Insert With Pump For Bladder Drainage