BEUDAMED
    Product Code: QQI FDA class 2 21 CFR 870.1405

    Interventional Cardiovascular Implant Simulation Software Device

    Cardiovascular

    The Interventional Cardiovascular Implant Simulation Software Device is a prescription software device that provides computer simulation of an interventional cardiovascular implant device within a patient's cardiovascular anatomy, performing computational modeling to predict the interaction between the device and the patient-specific anatomical environment to aid in procedure planning. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 870.1405 in the Cardiovascular specialty. It carries product code QQI and is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    4
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    2
    Years Active
    4

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    Basic Information

    Product Code
    QQI
    Device Class
    FDA class 2
    Regulation Number
    870.1405
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K250635 FEops HEARTguide Simulation Application
    K223809 PrecisionTAVI (v1.1)
    K214066 FEops HEARTguide
    DEN200030 FEops HEARTguide

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.