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510(k) Data Aggregation

    K Number
    K023368
    Device Name
    TRUCATH.IP
    Manufacturer
    AORTECH CRITICAL CARE LTD.
    Date Cleared
    2002-10-28

    (20 days)

    Product Code
    DFG
    Regulation Number
    866.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    AORTECH CRITICAL CARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TruCATH.IP 'S intended use is for the assessment of a patients 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. In addition the TCH 5100 product provides an additional infusion lumen that allows for continuous infusion.
    Device Description
    Not Found
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