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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
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    This is a PMA FDA document, not a 510k. 510ks do not contain acceptance criteria and performance data. They only demonstrate substantial equivalence to a predicate device.

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