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

    PEDIA-TRAKE CRICOTHYROTOMY KIT

    K Number: K840925 · Decision May 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    12
    Review Days
    61

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    Basic Information

    Device Name
    PEDIA-TRAKE CRICOTHYROTOMY KIT
    K Number
    K840925
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Medical Devices , Ltd.
    Date Received
    March 2, 1984
    Decision Date
    May 2, 1984
    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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    Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm

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    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)

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    Other Clearances by Intl. Medical Devices , Ltd.

    K Number Device Name
    K913540 PEDIA-THOR THORACOSTOMY KIT
    K913541 NEO-THOR THORACOSTOMY KIT
    K913539 THORACIC CATHTER STYLET
    K913542 THORACIC CATHETER WITH GUIDE
    K913543 THORACIC CATHETER STYLET
    K862909 RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM
    K850398 NU-CATH EMERGENCY KIT
    K843785 WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR
    K842666 NU-THOR THORACOSTOMY KIT
    K820778 RESPIRATION MONITOR 1000
    Search all 12 clearances from Intl. Medical Devices , Ltd. →