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510(k) Data Aggregation

    K Number
    K260149

    Validate with FDA (Live)

    Date Cleared
    2026-02-17

    (28 days)

    Product Code
    Regulation Number
    870.5150
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

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