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

    BALLOON CATHETERS

    K Number: K904669 · Decision Mar 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    142
    Review Days
    151

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    Basic Information

    Device Name
    BALLOON CATHETERS
    K Number
    K904669
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Olympus Corp.
    Date Received
    October 15, 1990
    Decision Date
    March 15, 1991
    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 Olympus Corp.

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    K934835 FLOVAL
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    K931994 RESECTOSCOPE SHEATH
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