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510(k) Data Aggregation

    K Number
    K173340
    Device Name
    Yikang Latex Foley Catheter
    Manufacturer
    Jiangxi Yikang Medical Instrument Group Co., LTD.
    Date Cleared
    2018-07-13

    (263 days)

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

    Jiangxi Yikang Medical Instrument Group Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The YiKang Latex Foley Catheter is intended to be placed in the bladder, through the urethra, to drain urine and other fluids from the urinary bladder.
    Device Description
    The YiKang Latex Foley Catheter is a flexible tubular device that is passed through the urethra into the bladder to drain urine and other fluids from the urinary bladder. The catheter is manufactured from natural latex, consists of a shaft with eyelets near the tip, balloon, drainage funnel, inflation funnel, irrigation funnel (only for 3-way) and valve. The eyelets allow for drainage of urine from the tip of the catheter through the drainage lumen. The balloon once inflated with sterile water retains the catheter within the bladder. The valve allows for inflation and deflation of the balloon. The YiKang Latex Foley Catheter offers various balloon volumes and shaft sizes to accommodate pediatric and adult use, it is supplied in French size ranging from 6Fr to 30Fr and balloon size 3cc(ml), the 6Fr, 8Fr and 10Fr are for pediatric use, remaining size for adult use. The YiKang Latex Foley Catheter consists of two types (2-way & 3-way) of devices. Two-way catheters are used for urological bladder drainage only. Three-way Foley catheters offer the option of irrigating the bladder through a 3rd lumen. The catheter is coated with a silicone elastomer through a dipping process. The product is individually packaged with a sterile barrier pouch which is produced of plastic film plus paper through heat sealing. The product is ethylene oxide sterilized (per ISO11135), the catheter is for single use.
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