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510(k) Data Aggregation

    K Number
    K111092
    Device Name
    ENGAGE/ENGAGE TR INTRODUCERS
    Manufacturer
    ST. JUDE MEDICAL
    Date Cleared
    2011-06-09

    (51 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Engage™ Introducer is indicated for the introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a blood vessel (including but not limited to femoral, radial, and brachial access) where minimizing blood loss is essential.

    The Engage TR™ Introducer is indicated for the introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a radial vessel where minimizing blood loss is essential.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) summary for the Engage™/Engage TR™ Introducer does not contain information about acceptance criteria or a study that proves the device meets those criteria.

    This document is a marketing clearance letter, which states that the device is substantially equivalent to legally marketed predicate devices. It does not include performance data, clinical study details, or specific acceptance criteria for the device itself.

    Therefore, I cannot extract the requested information from the provided text.

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