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

    VALVULOTOME BY KOVEN

    K Number: K080178 · Decision Jul 28, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    18
    Review Days
    186

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    Basic Information

    Device Name
    VALVULOTOME BY KOVEN
    K Number
    K080178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4885
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Koven Technology, Inc.
    Date Received
    January 24, 2008
    Decision Date
    July 28, 2008
    Product Code
    MGZ
    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
    MGZ Valvulotome

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