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

    COMMUNI-TRACH TUBE

    K Number: K841546 · Decision Apr 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    13
    Review Days
    14

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    Basic Information

    Device Name
    COMMUNI-TRACH TUBE
    K Number
    K841546
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Implant Technology, Inc.
    Date Received
    April 16, 1984
    Decision Date
    April 30, 1984
    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

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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 Implant Technology, Inc.

    K Number Device Name
    K921525 HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS
    K915617 LSF HA COATED FEMORAL HIP
    K920021 LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP
    K913616 LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP
    K902727 LSF CEMENTED FEMORAL HIP
    K901460 LSF(TM) TOTAL HIP SYSTEM
    K891472 IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR
    K884432 MODIFIED LSF TOTAL HIP SYSTEM
    K883212 LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT
    K855017 LSF* TOTAL HIP SYSTEM
    Search all 13 clearances from Implant Technology, Inc. →