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

    GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM

    K Number: K024071 · Decision Feb 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    8
    Review Days
    66

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    Basic Information

    Device Name
    GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
    K Number
    K024071
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guidant Corporation, Cardiac Surgery
    Date Received
    December 10, 2002
    Decision Date
    February 14, 2003
    Product Code
    NHW
    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
    NHW Electrode, Pacing And Cardioversion, Temporary, Epicardial

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    SYNCRUS INTERNAL CARDIOVERSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
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    K022718 VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
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