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510(k) Data Aggregation

    K Number
    K232788
    Device Name
    INSPIRA ART100
    Manufacturer
    Inspira Technologies Oxy B.H.N Ltd.
    Date Cleared
    2024-05-24

    (256 days)

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

    Inspira Technologies Oxy B.H.N Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INSPIRA™ ART100 system is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting six hours or less.
    Device Description
    The INSPIRA™ ART100 system 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 INSPIRA™ ART100 system consists of the following components: Controller Unit, Pump Drive Unit, Manual Pump Drive Unit, Blood Flow and Bubble Detection Sensor, Temperature Sensor, Cable adapters for Pressure Sensors, Cable adapters for Temperature Sensor, Oxygenator and Pump Drive Holders. The system is compatible with a Non-Roller Centrifygal Pump (Capiox iCP Centrifyqal Pump). The Inspira Pump Drives are magnetically coupled exclusively with the Capiox iCP Centrifugal Pump, designed and manufactured by Terumo Cardiovascular Systems Corporation, and can be supplied by Inspira. The INSPIRA™ ART100 system is intended to be used in conjunction with other previously 510(k)-cleared devices and sterile accessories such as cannulas, catheters, oxygenators, luer connectors, pressure sensors, supplied by hospital users or other manufacturers.
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