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

    EXPRESSWAY INTERMITTENT CATHETER

    K Number: K061766 · Decision Mar 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    81
    Applicant Total
    5
    Review Days
    260

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    Basic Information

    Device Name
    EXPRESSWAY INTERMITTENT CATHETER
    K Number
    K061766
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Percutaneous Systems, Incorporated
    Date Received
    June 22, 2006
    Decision Date
    March 9, 2007
    Product Code
    EZD
    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
    EZD Catheter, Straight

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    Other Clearances by Percutaneous Systems, Incorporated

    K Number Device Name
    K090485 COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003
    K052298 CYSTOGLIDE INTRODUCER SHEATH
    K052048 ACCORDION
    K042531 UPDATED SLIP UROLOGY INTRODUCER SHEATH