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

    MICRO-TRACHEOSTOMY CARE KIT

    K Number: K861645 · Decision May 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    6
    Review Days
    9

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    Basic Information

    Device Name
    MICRO-TRACHEOSTOMY CARE KIT
    K Number
    K861645
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Aci Medical, Inc.
    Date Received
    April 30, 1986
    Decision Date
    May 9, 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)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BTO), ordered by most recent decision date.

    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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    Pilling Tracheostomy Tubes

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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 Aci Medical, Inc.

    K Number Device Name
    K942530 ART-ASSIST MODEL AA-1000
    K903894 VENAPULSE MODELS VP-25 AND VP-50
    K903532 UNNA-SLEEVE(TM)
    K881291 AIR PLETHYSMOGRAPH MODEL APG-1000
    K844309 IV RATEMETER