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510(k) Data Aggregation

    K Number
    K962849
    Device Name
    CATHETER INSERTION TRAY
    Manufacturer
    MEDCARE MEDICAL GROUP, INC.
    Date Cleared
    1996-10-07

    (77 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K936261
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Catheter Insertion Trav is a single patient, single use, disposable device which is intended to conveniently provide components to aid in the administration of percutaneous catheterization.

    Device Description

    The Catheter Insertion Tray is intended to conveniently provide the components used to aid the insertion of percutaneous catheters such as: TPN/CVP catheters, PICC Line catheters, and Long Line catheters. The Catheter Insertion Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.

    AI/ML Overview

    This document does not contain the information required to answer your request. The provided text describes a "Catheter Insertion Tray" and its intended use, but it does not include any acceptance criteria, study details, performance metrics, or information about the development and validation of an AI device. The text is a 510(k) summary for a medical device (a catheter insertion tray), not an AI/ML device.

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