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

    OLYMPUS VALVULOTOME W/DETACHABLE TIP

    K Number: K895878 · Decision Jan 2, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    13
    Applicant Total
    142
    Review Days
    89

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    Basic Information

    Device Name
    OLYMPUS VALVULOTOME W/DETACHABLE TIP
    K Number
    K895878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Olympus Corp.
    Date Received
    October 5, 1989
    Decision Date
    January 2, 1990
    Product Code
    DWX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DWX Stripper, Artery, Intraluminal

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