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510(k) Data Aggregation

    K Number
    K221491
    Device Name
    Anivia SG1000 Pump Console
    Manufacturer
    APMTD, Inc.
    Date Cleared
    2023-02-03

    (256 days)

    Product Code
    DWA
    Regulation Number
    870.4380
    Why did this record match?
    Applicant Name (Manufacturer) :

    APMTD, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anivia SG1000 Pump Console is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass (up to 6 hours).
    Device Description
    The Anivia SG1000 Pump Console is a device for pumping blood without direct contact in an extracorporeal blood circulation circuit. The device is prescribed (Rx) by specialists to be used in Cardiopulmonary Bypass (CPB) procedures. The Anivia SG1000 Pump Console consists of the following modules: Display & Control Module, Pump Driver Module, Flow Bubble Sensor Module, and Backup Battery Module. It is intended to be used in conjunction with other previously 510(k)-cleared devices and sterile accessories such as cannulas, catheters, oxygenators, luer connectors and single use centrifugal pump heads, supplied by hospital users or other manufacturers.
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