BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    FEops HEARTguide Simulation Application

    K Number: K250635 · Decision Nov 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    4
    Review Days
    267

    Basic Information

    Device Name
    FEops HEARTguide Simulation Application
    K Number
    K250635
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1405
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Feops NV
    Date Received
    March 3, 2025
    Decision Date
    November 25, 2025
    Product Code
    QQI
    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
    QQI Interventional Cardiovascular Implant Simulation Software Device

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