BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    FFRangio System

    K Number: K182149 · Decision Dec 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    133

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    Basic Information

    Device Name
    FFRangio System
    K Number
    K182149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1415
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cathworks, Ltd.
    Date Received
    August 8, 2018
    Decision Date
    December 19, 2018
    Product Code
    QEK
    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
    QEK Angiographic Coronary Vascular Physiologic Simulation Software

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QEK), ordered by most recent decision date.

    FFRangio

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Cathworks, Ltd.

    K Number Device Name
    K192442 FFRangio