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510(k) Data Aggregation

    K Number
    K993245
    Device Name
    CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM
    Manufacturer
    ALBA CRITICAL CARE LTD
    Date Cleared
    1999-10-28

    (30 days)

    Product Code
    DYG
    Regulation Number
    870.1240
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALBA CRITICAL CARE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor system's intended use is for the assessment of a patient's haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also allows for sampling of venous blood.
    Device Description
    The Continuous Cardiac Output Pulmonary Artery Catheter, (catalogue # TruCATH), is a six-lumen, heparin-coated, polyvinyl chloride (PVC) flow-directed Pulmonary Artery Catheter. Once placed, the proximal extensions of the catheter are attached to the second part of the system, the Monitor. The Continuous Cardiac Output Monitor, (catalogue # TruCCOM), is a microprocessor-based computer which, when interfaced with the TruCATH, continuously calculates and displays cardiac output. The Monitor calculates cardiac output based on the thermodynamic principle of heat transfer using thermal power produced by the thermal coil area on the Catheter. Alternatively, the monitor can also be used by the clinician to measure cardiac output intermittently through using the injectate capabilities of the catheter.
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