BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)

    K Number: K862436 · Decision Nov 3, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    12
    Review Days
    130

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    Basic Information

    Device Name
    TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)
    K Number
    K862436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Acutronic Medical Systems AG
    Date Received
    June 26, 1986
    Decision Date
    November 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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    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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    BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube

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    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)

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    WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

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    Other Clearances by Acutronic Medical Systems AG

    K Number Device Name
    K012691 MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
    K012693 MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
    K936009 AMS 3000M
    K900745 VS-200S JET VENTILATOR
    K900744 AMS 3000 PORTABLE JET VENTILATOR
    K883865 EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010
    K863155 UNIVERSAL JET VENTILATOR MODEL AMS-1000
    K863154 HEATED JET HUMIDIFIER MODEL AMS-1020
    K862435 DOUBLE LUMEN E T ADAPTOR
    K862433 UNI-JET CONNECTOR
    Search all 12 clearances from Acutronic Medical Systems AG →