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

    TRIACTIV SYSTEM

    K Number: K042040 · Decision Mar 23, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    21
    Applicant Total
    19
    Review Days
    237

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    Basic Information

    Device Name
    TRIACTIV SYSTEM
    K Number
    K042040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kensey Nash Corp.
    Date Received
    July 29, 2004
    Decision Date
    March 23, 2005
    Product Code
    NFA
    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
    NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

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