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

    Vivio® LVEDP System

    K Number: K223905 · Decision Oct 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    282

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    Basic Information

    Device Name
    Vivio® LVEDP System
    K Number
    K223905
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avicena, LLC
    Date Received
    December 28, 2022
    Decision Date
    October 6, 2023
    Product Code
    QUO
    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
    QUO Adjunctive Heart Failure Status Indicator

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    Other Clearances by Avicena, LLC

    K Number Device Name
    K183710 Vivio System