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

    HEARTFLOW FFRCT

    K Number: DEN130045 · Decision Nov 26, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    387

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    Basic Information

    Device Name
    HEARTFLOW FFRCT
    K Number
    DEN130045
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.1415
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Heartflow
    Date Received
    November 4, 2013
    Decision Date
    November 26, 2014
    Product Code
    PJA
    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
    PJA Coronary Vascular Physiologic Simulation Software

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