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510(k) Data Aggregation

    K Number
    K252794

    Validate with FDA (Live)

    Date Cleared
    2026-01-08

    (128 days)

    Product Code
    Regulation Number
    870.1220
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vision-MR Diagnostic Catheter is intended for cardiac electrophysiological mapping (stimulating and recording) during electrophysiology procedures to diagnose arrhythmias and/or guide therapeutic decisions in patients age 18 years or older.

    Device Description

    The Vision-MR Diagnostic Catheter is an MR Conditional 9F (3.0 mm) catheter with a deflectable tip and two gold electrodes (1.3mm spacing): a 1.5mm tip electrode and a 1.4mm ring electrode. The catheter is designed to facilitate electrophysiological mapping of the heart (sensing and pacing) during cardiac electrophysiology procedures. The distal end of the catheter includes a receive coil to allow for MR tracking. The catheter is a sterile, single-use device.

    The Vision-MR Diagnostic Catheter is a uni-directional deflectable catheter that is 115cm in length. The catheter handle incorporates a thumb control that deflects the catheter when pushed forward.

    The Vision-MR Diagnostic Catheter must be used with the Advantage-MR™ EP Recorder/Stimulator System. Advantage-MR provides EP recording and cardiac stimulation capabilities and is the interface between the catheter and compatible medical devices, such as MR tracking systems. The Vision-MR Diagnostic Catheter interfaces with the Advantage-MR EP Recorder/Stimulator System via a sterile accessory cable (Vision-MR™ Diagnostic Cable 2.0).

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