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

    GUIDANT MICROWAVE ABLATION SYSTEM

    K Number: K041340 · Decision Jul 28, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    67
    Applicant Total
    8
    Review Days
    69

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    Basic Information

    Device Name
    GUIDANT MICROWAVE ABLATION SYSTEM
    K Number
    K041340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guidant Corporation, Cardiac Surgery
    Date Received
    May 20, 2004
    Decision Date
    July 28, 2004
    Product Code
    NEY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    NEY System, Ablation, Microwave And Accessories

    Similar 510(k) Clearances

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    Other Clearances by Guidant Corporation, Cardiac Surgery

    K Number Device Name
    K080169 HEARTSTRING III PROXIMAL SEAL SYSTEM
    K023630 ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400
    K024071 GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
    K023629 ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200
    K022718 VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
    K020701 SYNCRUS INTERNAL CARDIOVERSION SYSTEM
    K020143 VASOVIEW 5 HARVESTING CANNULA