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510(k) Data Aggregation

    K Number
    K101883
    Device Name
    6F ENGAGE/ENGAGE TR INTRODUCER
    Manufacturer
    ST. JUDE MEDICAL
    Date Cleared
    2010-09-07

    (63 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K101882
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into The introduction of the catheero, emoral, radial, and brachial access) where minimizing blood loss is essential.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Engage™/Engage™ TR Introducer). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

    This document does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment for an AI/ML medical device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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