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510(k) Data Aggregation

    K Number
    K073631
    Device Name
    ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100
    Date Cleared
    2008-06-27

    (184 days)

    Product Code
    Regulation Number
    870.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORQIS MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Orqis Extracorporeal Blood Pumping system is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants, etc). The Orqis Pump Tubing is indicated for use in extracorporeal circuits for circulatory support lasting six-hours or less.
    Device Description
    The Orqis Extracorporeal Blood Pumping System consists of a pump, independent motor unit, a controller, a flow sensor, and some pump tubing. The system also has two accessories: a holster for the pump and motor, and a controller stand. The Orqis Blood Pump is a sterile, single-use, disposable, non-pulsatile, non-roller pump that utilizes a rotor to impart energy to the blood in an extracorporeal circuit through centrifugal forces. The inlet of the pump runs concentric with the axis of the rotor. The Orqis Motor is a small, compact, reusable unit that holds the disposable blood pump and drives the rotor inside the blood pump. The Motor turns a magnet that is hermetically sealed in the pump's rotor at a speed that is set by the controller. The outer shell of the motor is built from aluminum and polycarbonate. The motor is provided non-sterile. The Orqis Controller is a microprocessor-based device, which drives and controls the blood pump, through the motor. The Controller also provides monitoring of motor speed, fluid flow, and pressure through the use of alphanumeric display and audible and visual alarms. The Orqis Flow Sensor is an ultrasonic flow meter that measures fluid flow through standard 3/8" tubing. The Orqis Pump Tubing is medical grade PVC tubing used to connect the Blood Pump to external devices. The Pump Tubing is provided sterile.
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