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

    CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM

    K Number: K012056 · Decision Aug 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    7
    Review Days
    30

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    Basic Information

    Device Name
    CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
    K Number
    K012056
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Cordis Europa, N.V.
    Date Received
    July 2, 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 Europa, N.V.

    K Number Device Name
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    K060302 INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
    K043605 INSCOPE 3-STAGE BALLOON DILATOR
    K040413 CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
    K032737 CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA