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510(k) Data Aggregation

    K Number
    K960755
    Device Name
    CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS
    Manufacturer
    MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
    Date Cleared
    1996-05-23

    (90 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic CardioTherm™ Blood Cardioplegia System is intended for mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.
    Device Description
    Each Medtronic CardioTherm™ Blood Cardioplegia System is a single use, disposable device designed to mix arterial blood from an oxygenator with asanguineous cardioplegia solution in specific ratios devending on the tubing set configurations. The blood/cardioplegia solution is then cooled/warmed and delivered to the patient. The Medtronic CardioTherm™ Cardioplegia Heat Exchanger consists of a polycarbonate housing which incorporates a bubble chamber. A stopcock is attached to the upper luer port of the housing lid allowing for air venting through a purge line during priming and pressure monitoring through a vented or nonvented pressure monitoring line throughout the procedure. A temperature probe port is located adjacent to the blood outlet port at the bottom of the device, allowing for temperature monitoring of the blood/cardioplegia solution prior to patient delivery. The heat exchanger housing contains nonporous polypropylene hollow fibers, which are supported on their exterior by a polyethylene screen. These polypropylene fibers run longitudinally through the polycarbonate chamber. Blood/cardioplegia solution flows through the polypropylene hollow fibers. The walls of these fibers provide a barrier between the blood/cardioplegia solution and the cooling/warming water.
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    K Number
    K953564
    Device Name
    MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE
    Manufacturer
    MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
    Date Cleared
    1996-02-02

    (186 days)

    Product Code
    DTL
    Regulation Number
    870.4290
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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