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

    Anivia SG1000 Pump Console

    K Number: K230698 · Decision Apr 18, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    36
    Applicant Total
    2
    Review Days
    36

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    Basic Information

    Device Name
    Anivia SG1000 Pump Console
    K Number
    K230698
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4380
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apmtd, Inc.
    Date Received
    March 13, 2023
    Decision Date
    April 18, 2023
    Product Code
    DWA
    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
    DWA Control, Pump Speed, Cardiopulmonary Bypass

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    Other Clearances by Apmtd, Inc.

    K Number Device Name
    K221491 Anivia SG1000 Pump Console