BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET

    K Number: K133173 · Decision May 23, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    64
    Review Days
    218

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    Basic Information

    Device Name
    RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
    K Number
    K133173
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Teleflexmedical, Inc.
    Date Received
    October 17, 2013
    Decision Date
    May 23, 2014
    Product Code
    JOH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOH Tube Tracheostomy And Tube Cuff

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    Other Clearances by Teleflexmedical, Inc.

    K Number Device Name
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    K182847 Hudson RCI Voldyne Volumetric Exerciser
    K181979 Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
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    K181852 Percuvance Percutaneous Surgical System
    K173280 Neonatal ConchaSmart Breathing Circuits
    K172775 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
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