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

    MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO.

    K Number: K871199 · Decision Jun 8, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    6
    Review Days
    75

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    Basic Information

    Device Name
    MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO.
    K Number
    K871199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Frederic J. Toye, M.D.
    Date Received
    March 25, 1987
    Decision Date
    June 8, 1987
    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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    5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm

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    Other Clearances by Frederic J. Toye, M.D.

    K Number Device Name
    K822440 PERCUTANEOUS CRICOTHYROIDOTOMY
    K832498 PERCUTANEOUS TRACHEOSTOMY DEVICE
    K830509 EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO-
    K821821 PERCUTANEOUS TRACHEOSTOMY DEVICE
    K801379 CUFFED TRACHEA TUBE FOR USE W/PERTRACH