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510(k) Data Aggregation

    K Number
    K243175
    Device Name
    Disposable Intermittent Catheter (TPU Catheter)
    Date Cleared
    2025-06-26

    (269 days)

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

    Chengdu Daxan Innovative Medical Tech. Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.
    Device Description
    The subject device is intended used for drainage of the urinary system, sterile and for single use. Duration of use ≤ 24 hours. The subject device is supplied in four forms: Uncoated type, Normal type, Water sachet type, Ready-to-use type. The Disposable Intermittent Catheter is made from the TPU, and the hydrophilic coating (optional). The surface hydrophilic coating is made from polyvinyl pyrrolidone. The free contact sleeve is optional.
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    K Number
    K212567
    Device Name
    PVC Hydrophilic Urethral Catheter
    Date Cleared
    2022-12-07

    (478 days)

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

    Chengdu Daxan Innovative Medical Tech. Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization -CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.
    Device Description
    The PVC Hydrophilic Urethral Catheter is a single use urinary catheter designed for clean intermittent catheterization, drainage of bladder. The device consists of disposable PVC (medical grade) catheter coated with hydrophilic polymer with/without water sachet (pure water). The catheters are coated with a coating containing polyvinyl pyrrolidone (PVP) - a kind of hydrophilic polymer, which binds the water molecules to the catheter to reduce the risk of friction while inserting the catheter into the urethra. Coating is activated by the water by squeezing the water sachet or purified water. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The PVC Hydrophilic Urethral Catheter is supplied in French size ranging from 8 to 18. It is available for male and female.
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