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510(k) Data Aggregation

    K Number
    K233094
    Device Name
    Wellead® Latex Foley Catheter
    Manufacturer
    Well Lead Medical (Hainan) Co., Ltd.
    Date Cleared
    2024-06-06

    (254 days)

    Product Code
    MJC, EYB, EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Well Lead Medical (Hainan) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Latex Foley Catheter is inserted into the bladder through urethra and are indicated for routine urine drainage or for routine post-operative drainage and bladder irrigation.
    Device Description
    The Latex Foley Catheter is inserted through the urethra during urinary catheterization and goes into the bladder for urine drainage or irrigation. It consists of a shaft, a drainage funnel, an inflation funnel, an irrigation funnel (if present), a balloon and a valve. The device is made from latex with silicone coating and available in different types (e.g., straight, Tiemann, female etc.) and sizes for adult and pediatric use.
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