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510(k) Data Aggregation

    K Number
    K081878
    Device Name
    LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2009-01-27

    (209 days)

    Product Code
    DQY,DOY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TT® Introducer is used to introduce balloon catheters, closed-end catheters, and other vascular devices.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the LeMaitre TT® Tortuous Tracker Introducer Delivery System. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information.

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