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    K Number
    K030209
    Device Name
    MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
    Manufacturer
    THE KENDALL COMPANY
    Date Cleared
    2003-05-13

    (112 days)

    Product Code
    MPB
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MAHURKAR OPLUS CATHETER, MODEL 13.5 FR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MAHURKAR® QPLUS® Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.

    Device Description

    The MAHURKAR® QPLUS® Catheter has a 13.5Fr radiopaque polyurethane catheter shaft with two large lumens (arterial and venous) running longitudinally along the length of the catheter shaft. The catheter version with a straight shaft either has curved extensions or straight extensions. The catheter version with a pre-curved shaft has straight extensions.

    MAHURKAR® QPLUS® Catheter is available in kit or tray configuration which contains the sterile catheter as well as accessory items needed for insertion.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification for the MAHURKAR® QPLUS® Catheter. This document is for a medical device and therefore does not contain information about software, algorithms, or AI. Consequently, I cannot address your request for specific details regarding an AI device's acceptance criteria and study information, as these are not relevant to the provided text.

    The document primarily focuses on establishing substantial equivalence to previously marketed predicate devices (MAHURKAR® Triple Lumen Catheter and MAHURKAR® Dual Lumen Catheter) based on design, materials, physical characteristics, and performance characteristics.

    Therefore, for each of your points, the information is not applicable or cannot be extracted from the provided text.

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