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

    TRACHEOSTOMY TUBE AND CUFF

    K Number: K912124 · Decision Aug 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    23
    Review Days
    95

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    Basic Information

    Device Name
    TRACHEOSTOMY TUBE AND CUFF
    K Number
    K912124
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Concord/Portex
    Date Received
    May 13, 1991
    Decision Date
    August 16, 1991
    Product Code
    BTO
    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
    BTO Tube, Tracheostomy (W/Wo Connector)

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    Other Clearances by Concord/Portex

    K Number Device Name
    K923559 STERI-CATH MDI
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    K930286 DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS
    K923127 NEEDLE-PRO CARTRIDGE
    K923910 HEAT MOISTURE CONDENSER
    K922749 LOW PROFILE TRACHEOSTOMY TUBE
    K922445 VACU-PRO
    K915452 ANESTHESIA BREATHING CIRCUIT
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