BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER

    K Number: K140667 · Decision Dec 15, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    17
    Review Days
    272

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    Basic Information

    Device Name
    WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
    K Number
    K140667
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Well Lead Medical Co., Ltd.
    Date Received
    March 18, 2014
    Decision Date
    December 15, 2014
    Product Code
    EZL
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EZL Catheter, Retention Type, Balloon

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    Other Clearances by Well Lead Medical Co., Ltd.

    K Number Device Name
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    K211543 Wei Nasal Jet Tube
    K211814 Wellead Endoscopic Seal
    K202134 Well Lead All Silicone Foley Catheter with Temperature Sensor
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    K182739 Endotracheal Tube with Evacuation Lumen
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