BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED

    K Number: K060302 · Decision Apr 11, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    39
    Applicant Total
    7
    Review Days
    64

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    Basic Information

    Device Name
    INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
    K Number
    K060302
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5365
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cordis Europa, N.V.
    Date Received
    February 6, 2006
    Decision Date
    April 11, 2006
    Product Code
    KNQ
    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
    KNQ Dilator, Esophageal

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    Other Clearances by Cordis Europa, N.V.

    K Number Device Name
    K071189 CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
    K063563 CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER
    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
    K012056 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM