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510(k) Data Aggregation

    K Number
    K190213
    Device Name
    Yikang Endotracheal Tube
    Date Cleared
    2019-09-06

    (214 days)

    Product Code
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangxi Yikang Medical Instrument Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for oral or nasal intubation and for airway management.
    Device Description
    Yikang endotracheal tube is a device intended for oral or nasal intubation and for airway management. It is a sterile and single use device, it is made from medical grade PVC. The Yikang endotracheal tube has cuffed and uncuffed, and is available in size I.D. 2.0mm through I.D. 10.0mm, and has a Murphy eye. It basically consists of tube shaft, cuff, inflation line, pilot balloon, one-way valve, and a male 15mm conical connector. A radiopaque line is incorporated into the full length of the tracheal tube. When used tracheal tube is inserted through the trachea to convey gases to and from the trachea. Cuffed tracheal tube is intended to seal and protect aspiration of secretions, and to provide an unobstructed airway in patients during ventilation. A radiopaque line helps to determine proper placement of the tracheal tube with the characterization of visibility of tracheal tube in X-rays.
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    K Number
    K173340
    Device Name
    Yikang Latex Foley Catheter
    Date Cleared
    2018-07-13

    (263 days)

    Product Code
    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 AuthorizedThirdparty
    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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