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510(k) Data Aggregation

    K Number
    K241851
    Device Name
    Versus™ Catheter (VS110-8B)
    Manufacturer
    Liquet Medical Inc.
    Date Cleared
    2024-11-25

    (151 days)

    Product Code
    QEY, DQO, DYG, KRA
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Liquet Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Versus™ Catheter is indicated for: The controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients. The assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring.
    Device Description
    The Versus™ Pulmonary Artery Catheter is a dual-tip infusion catheter. Two lumens access and deliver physician-specified fluids, including thrombolytics, into the pulmonary arteries of each lung via a single access site. The Secondary Catheter tip telescopes independently to facilitate infusion into the contralateral lung. The device may allow for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Pressure is measured through an interface between the catheter's fluid lumen and an externally located, FDA-cleared, pressure transducer. The device may include an additional lumen that is in communication with a distal flow-directed balloon.
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