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    FDA De Novo (DEN130045) HeartFlow FFRCT v1.4

    FDA De Novo (DEN130045) HeartFlow FFRCT v1.4

    $89.00 USD
    $89.00 USD
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    Device Name: HeartFlow FFRCT v1.4

    Regulation Number: 21 CFR 870.1415

    Regulation Name: Coronary Artery Disease (CAD) Analysis Software for Clinical Use

    Product Code: PJA

    Device Class: Class II (Special Controls), Prescription Use

    Decision Date: November 26, 2014

    De Novo Number: DEN130045

    Applicant: HeartFlow, Inc., Redwood City, CA

    Total pages: 658
    Fully redacted pages: 642
    Content pages: 16
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