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

    DEEPVESSEL FFR

    K Number: K213657 · Decision Apr 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    133

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    Basic Information

    Device Name
    DEEPVESSEL FFR
    K Number
    K213657
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1415
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Keyamed Na, Inc.
    Date Received
    November 19, 2021
    Decision Date
    April 1, 2022
    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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