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510(k) Data Aggregation

    K Number
    K192238
    Device Name
    AC3 Series Intra-Aortic Balloon Pump (IABP)
    Manufacturer
    Arrow International, Teleflex
    Date Cleared
    2019-11-12

    (85 days)

    Product Code
    DSP
    Regulation Number
    870.3535
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arrow International, Teleflex

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AC3™ Intra-Aortic Balloon Pump is clinically indicated for use for the following conditions: - · Acute Coronary Syndrome - · Cardiac and Non-Cardiac Surgery - · Complications of Heart Failure
    Device Description
    The AC3™ Series IABP System provides counter-pulsation therapy to adult patients with impaired left ventricular (LV) function. It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles. The IABP is attached to an intra-aortic balloon catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta. The IABP delivers Helium (HE) into the IAB catheter during diastole to displace blood above and below the IAB, increasing blood pressure and perfusion to organs close to the IAB catheter. The IABP deflates or removes HE from the IAB catheter just prior to or in the early phase of systole, reducing the pressure in the aorta and therefore the pressure the LV must generate to open the aortic valve and eject its contents into the circulatory system. This results in a decrease in work and oxygen demand. The AC3™ Series IABP System consists of two main components: - . The pump control/display module which incorporates a touch screen and keypad for system operation, and - The pneumatic drive module which is incorporated into the body of the device ● The AC3™ Series IABP is designed to be used with 30, 35, 40 and 50cc Intra-aortic balloons with the appropriate connectors.
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