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

    CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT

    K Number: K012090 · Decision Aug 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    4
    Review Days
    27

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    Basic Information

    Device Name
    CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
    K Number
    K012090
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Cordis, A Johnson & Johnson Co.
    Date Received
    July 5, 2001
    Decision Date
    August 1, 2001
    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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    Other Clearances by Cordis, A Johnson & Johnson Co.

    K Number Device Name
    K140286 OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
    K013581 CORDIS AVIATOR PERIPHERAL DILATATION CATHETER
    K992755 CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE