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

    TRACHEOSTOMY CARE KIT

    K Number: K850456 · Decision Mar 11, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    5
    Review Days
    33

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    Basic Information

    Device Name
    TRACHEOSTOMY CARE KIT
    K Number
    K850456
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Excel Health Care Products
    Date Received
    February 6, 1985
    Decision Date
    March 11, 1985
    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 Excel Health Care Products

    K Number Device Name
    K850960 NON-ABSORBENT DRAPES & ABSORBENT TOWELS
    K850326 STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH
    K850325 STERILE SUTURE REMOVAL KIT
    K850199 POLY-LINED TOWEL/DRAPE LINE