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

    KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE

    K Number: K961977 · Decision Jul 31, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    33
    Applicant Total
    66
    Review Days
    72

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    Basic Information

    Device Name
    KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
    K Number
    K961977
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5740
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kendall Healthcare Products Co. Div.Of Tyco Health
    Date Received
    May 20, 1996
    Decision Date
    July 31, 1996
    Product Code
    CBI
    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
    CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

    Similar 510(k) Clearances

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    Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)

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    Other Clearances by Kendall Healthcare Products Co. Div.Of Tyco Health

    K Number Device Name
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    K973619 KENDALL CURITY NON-ADHERING DRESSING
    K973509 KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
    K973546 KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
    K970266 KENDALL HYDROPHILIC POWDER WOUND DRESSING
    K963446 KENDALL DUAL LUMEN CATHETER
    K964899 KENDALL CURITY URETERAL CATHETER
    K964519 CURITY THORACENTESIS TRAY
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