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

    3 WAY SILICONE FOLEY BALLOON CATHETER

    K Number: K091767 · Decision Oct 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    104
    Review Days
    114

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    Basic Information

    Device Name
    3 WAY SILICONE FOLEY BALLOON CATHETER
    K Number
    K091767
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Urological, Inc.
    Date Received
    June 17, 2009
    Decision Date
    October 9, 2009
    Product Code
    EZL
    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
    EZL Catheter, Retention Type, Balloon

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