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

    TRACH CARE KIT

    K Number: K790437 · Decision Apr 3, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    127
    Review Days
    27

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    Basic Information

    Device Name
    TRACH CARE KIT
    K Number
    K790437
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Abco Dealers, Inc.
    Date Received
    March 7, 1979
    Decision Date
    April 3, 1979
    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 Abco Dealers, Inc.

    K Number Device Name
    K905025 DIGITAL THERMOMETER KITS
    K882304 DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)
    K880892 BLOOD COLLECTING NEEDLE AND HOLDERS
    K880894 ALLERGIST SYRINGES
    K872875 STRETCH GAUZE BANDAGES
    K872874 MICROSCOPE COVER GLASSES
    K872797 NON-SKID SHOE COVERS
    K871465 THERMOMETER SHEATHS
    K862726 DISPOSABLE SHOE COVERS AND NURSES CAPS
    K862111 ARMBOARDS, REUSABLE AND DISPOSABLE
    Search all 127 clearances from Abco Dealers, Inc. →