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

    Well Lead PVC Urethral Catheter

    K Number: K142563 · Decision Oct 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    81
    Applicant Total
    17
    Review Days
    47

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    Basic Information

    Device Name
    Well Lead PVC Urethral Catheter
    K Number
    K142563
    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
    September 11, 2014
    Decision Date
    October 28, 2014
    Product Code
    EZD
    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
    EZD Catheter, Straight

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    Other Clearances by Well Lead Medical Co., Ltd.

    K Number Device Name
    K241734 Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
    K220722 PVC Hydrophilic Urethral Catheter
    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
    Search all 17 clearances from Well Lead Medical Co., Ltd. →