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

    FLEXIMA BILIARY CATHETER

    K Number: K023870 · Decision Dec 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    5
    Review Days
    30

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    Basic Information

    Device Name
    FLEXIMA BILIARY CATHETER
    K Number
    K023870
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific/Medi-Tech
    Date Received
    November 20, 2002
    Decision Date
    December 20, 2002
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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