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

    TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER

    K Number: K854252 · Decision Feb 3, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    8
    Review Days
    104

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    Basic Information

    Device Name
    TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER
    K Number
    K854252
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Applicant
    Transtracheal Systems
    Date Received
    October 22, 1985
    Decision Date
    February 3, 1986
    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 Transtracheal Systems

    K Number Device Name
    K982943 TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
    K981078 TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000
    K981080 SCOOP 1
    K962944 TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
    K904748 TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100
    K904749 TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200
    K902281 MODIFIED SCOOP TRANSTRACHEAL CATHETERS