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510(k) Data Aggregation

    K Number
    K151745
    Device Name
    FULL CARE Disposable PVC Nelaton Catheter
    Date Cleared
    2016-03-03

    (248 days)

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

    SHAOXING FUQING HEALTH PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FULL CARE Disposable PVC Nelaton Catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain. The urinary catheter comes in a variety of sizes packaged sterile for single-use.
    Device Description
    The FULL CARE Disposable PVC Nelaton Catheter is a sterile, single use device designed as an intermittent pathway for drainage of the bladder. It is available for male, female and pediatric, in uncoated and coated variants and in two different tip configurations (straight and rounded). There are two drainage eyelets on the catheter. The PVC catheter is designed as an intermittent pathway for drainage of the bladder. The devices consist of the following parts (with different combination): Intermittent Urinary Catheter; hydrophilic coated Nelaton Catheter; water sachet; collection bag; gauze tissue; povidone iodine swabs; two gloves; underpad; BZK; Lubricant; Interface tube; pouch. The device is made of polyvinyl chloride. The catheter is provided sterile in a variety of lengths and sizes.
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