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

    TRACHEOSTOMY CARE KIT

    K Number: K941470 · Decision Feb 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    14
    Review Days
    323

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    Basic Information

    Device Name
    TRACHEOSTOMY CARE KIT
    K Number
    K941470
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Clinical Resources, Inc.
    Date Received
    March 28, 1994
    Decision Date
    February 14, 1995
    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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    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 Clinical Resources, Inc.

    K Number Device Name
    K944882 IRRIGATION TRAY
    K944881 SKIN SCRUB TRAY
    K944879 GAUZE SPONGES
    K945021 FLUFF GAUZE SPONGE
    K945019 FLUFF GAUXZE ROLL
    K945020 FLUFF GAUZE SPONGE
    K944880 BODILY FLUID DISPOSAL KIT
    K941469 IV START KIT
    K941468 DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
    K941471 CENTRAL LINE DRESSING CHANGE TRAY
    Search all 14 clearances from Clinical Resources, Inc. →