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510(k) Data Aggregation

    K Number
    K213492
    Device Name
    Dib UltraNav Transseptal Catheter System
    Date Cleared
    2022-03-24

    (143 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dib UltraNav Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dib UltraNav Transseptal Catheter System is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal puncture.
    Device Description
    The Dib UltraNav Transseptal Catheter System is a single-use, dual lumen, non-steerable intravascular catheter and handle to be used during a percutaneous procedure to support visualization and puncture of the septum. It is to be used to cross the interatrial septum and enable placement of a guidewire into the left side of the heart. The UltraNav catheter system is used with off-the-shelf transseptal needles and ultrasound catheters (not provided).
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