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

    BD Curve Ascites Shunt

    K Number: K170405 · Decision Nov 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    34
    Review Days
    265

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    Basic Information

    Device Name
    BD Curve Ascites Shunt
    K Number
    K170405
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5955
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Care Fusion
    Date Received
    February 10, 2017
    Decision Date
    November 2, 2017
    Product Code
    KPM
    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
    KPM Shunt, Peritoneal

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