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

    ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES

    K Number: K060094 · Decision May 8, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    2
    Review Days
    116

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    Basic Information

    Device Name
    ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES
    K Number
    K060094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arcadia Medical Corporation
    Date Received
    January 12, 2006
    Decision Date
    May 8, 2006
    Product Code
    BTR
    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
    BTR Tube, Tracheal (W/Wo Connector)

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    Other Clearances by Arcadia Medical Corporation

    K Number Device Name
    K031553 SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES