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

    PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE

    K Number: K962175 · Decision Jan 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    22
    Review Days
    226

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    Basic Information

    Device Name
    PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
    K Number
    K962175
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smiths Industries Medical Systems, Inc.
    Date Received
    June 5, 1996
    Decision Date
    January 17, 1997
    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 Smiths Industries Medical Systems, Inc.

    K Number Device Name
    K972385 FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
    K965017 REGIONAL ANESTHESIA TRAYS
    K962931 SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
    K963570 SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
    K960429 PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
    K953485 SIMS CPAP SYSTEM
    K953483 SIMS BLUE LINE ENDOBRONCHIAL TUBE
    K932946 WALLACE IV CANNULA
    K932947 WALLACE Y-CAN
    K952516 PRO-VENT, LINE DRAW, PULSATOR
    Search all 22 clearances from Smiths Industries Medical Systems, Inc. →