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

    REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)

    K Number: K810321 · Decision Mar 4, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    8
    Review Days
    26

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    Basic Information

    Device Name
    REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)
    K Number
    K810321
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    National Catheter Co. Div. Mallinckrodt
    Date Received
    February 6, 1981
    Decision Date
    March 4, 1981
    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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    BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube

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    Other Clearances by National Catheter Co. Div. Mallinckrodt

    K Number Device Name
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    K801005 MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)
    K791190 STETHOSCOPE WITH TEMPERATURE SENSOR
    K781665 TUBE, LEATHERMAN/IMBRUCE
    K770727 MANIPULATOR & INJECTOR, UTERINE