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

    PrecisionTAVI (v1.1)

    K Number: K223809 · Decision May 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    161

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    Basic Information

    Device Name
    PrecisionTAVI (v1.1)
    K Number
    K223809
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1405
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dasi Simulations
    Date Received
    December 20, 2022
    Decision Date
    May 30, 2023
    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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