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

    WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL

    K Number: K110269 · Decision Aug 26, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    17
    Review Days
    211

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    Basic Information

    Device Name
    WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
    K Number
    K110269
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Well Lead Medical Co., Ltd.
    Date Received
    January 27, 2011
    Decision Date
    August 26, 2011
    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 Well Lead Medical Co., Ltd.

    K Number Device Name
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    K220036 Wellead Ureteral Catheter
    K211543 Wei Nasal Jet Tube
    K211814 Wellead Endoscopic Seal
    K202134 Well Lead All Silicone Foley Catheter with Temperature Sensor
    K203119 ClearPetra Suction-Evacuation Sheath
    K182739 Endotracheal Tube with Evacuation Lumen
    K162340 Stomach Tube
    K160801 Well Lead Extraction Bag
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