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

    RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET

    K Number: K122235 · Decision Sep 6, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    107
    Applicant Total
    52
    Review Days
    407

    Basic Information

    Device Name
    RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
    K Number
    K122235
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Teleflex Medical, Inc.
    Date Received
    July 26, 2012
    Decision Date
    September 6, 2013
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JOH), ordered by most recent decision date.

    Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TRACOE vario

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Shiley Neonatal/Pediatric Tracheostomy Tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Teleflex Medical, Inc.

    K Number Device Name
    K232469 Rüsch Latex Gold Foley Catheter
    K212077 Teleflex Rusch SoftSimplastic Foley Catheters
    K181979 Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
    K181852 Percuvance Percutaneous Surgical System
    K172775 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
    K161770 Rusch Silicone Foley Catheter
    K153089 'cottony' II TAPE, PLEDGETS
    K153010 Hudson RCI AquaPak Sterile Prefilled Nebulizers
    K153076 silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL
    K153063 PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM
    Search all 52 clearances from Teleflex Medical, Inc. →