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510(k) Data Aggregation

    K Number
    DEN210006
    Device Name
    Hemolung Respiratory Assist System
    Date Cleared
    2021-11-13

    (254 days)

    Product Code
    Regulation Number
    870.4150
    Why did this record match?
    Product Code :

    QOH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Hemolung Respiratory Assist System is indicated for respiratory support that provides extracorporeal carbon dioxide (CO2) removal from the patient's blood for up to 5 days in adults with acute, reversible respiratory failure for whom ventilation of CO2 cannot be adequately or safely achieved using other available treatment options and continued clinical deterioration is expected.
    Device Description
    The Hemolung RAS provides low blood flow, veno-venous extracorporeal carbon dioxide removal (ECCO2R) using a single, 15.5 French dual lumen catheter inserted percutaneously in the femoral or jugular vein. The Hemolung RAS is not intended to provide therapeutic levels of oxygenation. During Hemolung therapy, blood passing through the circuit is oxygenated via room air sweep gas; however, at ultra-low extracorporeal blood flows, the limited oxygen carrying capacity of blood precludes meaningful oxygenation of mixed venous blood. The Hemolung RAS consists of three main components: C. Hemolung Controller, A. Hemolung Cartridge, and B. Hemolung Catheter.
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