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510(k) Data Aggregation

    K Number
    K130908
    Device Name
    DISPOSABLE SILICONE FOLEY CATHETER
    Manufacturer
    GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD
    Date Cleared
    2013-10-03

    (185 days)

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

    GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Two-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage for urological use only; the indwell time of the proposed device is no more than 30 days. Three-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage and bladder irrigation for urological use only; the indwell time of the proposed device is no more than 30 days.
    Device Description
    The Disposable Silicone Foley Catheter is available in two types, two-way disposable silicone Foley catheter and three-way disposable silicone Foley catheter. The two-way disposable silicone Foley catheter is composed of a double lumen tube, a double lumen hub, one balloon and a tip. The three-way disposable silicone Foley catheter is composed of a triple lumen tube, a triple lumen hub, one balloon and a tip. The proposed device is supplied in French size ranging from 6 to 26. It is available in 310mm and 400mm length with various balloon sizes. The devices are applied for male and female; the 6Fr, 8Fr and 10Fr catheters are for pediatric, and others are for adult. The Disposable Silicone Foley Catheter is provided EO sterilized as a single used device.
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