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510(k) Data Aggregation

    K Number
    K974764
    Device Name
    INTROSYTE CATHETER
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Date Cleared
    1998-02-26

    (69 days)

    Product Code
    FOZ,DEC
    Regulation Number
    880.5200
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TO FACILITATE THE PLACEMENT OF DEVICES SUCH AS GUIDEWIRES, INDWELLING CENTRAL VENOUS CATHETERS, PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS, AND MIDLINE CATHETERS INTO THE VASCULAR SYSTEM.

    Device Description

    The subject catheter is a short term, single use introducer catheter of various gauges and lengths which is designed to split and peel away following use. It is inserted into the vascular system over a needle.

    AI/ML Overview

    The provided text is a compilation of FDA correspondence regarding a 510(k) premarket notification for the "INTROSYTE™ Catheters." It details the device's name, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance studies, or training data.

    The document is purely administrative, confirming the FDA's review and determination of substantial equivalence, which allows the submitter to market the device. It focuses on regulatory compliance rather than performance evaluation against specific metrics.

    Therefore, I cannot provide the requested information from the given text.

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