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510(k) Data Aggregation

    K Number
    K230756
    Device Name
    TK Pre-Filled Normal Saline Flush Syringe
    Manufacturer
    Anhui Tiankang Medical Technology Co., Ltd.
    Date Cleared
    2023-08-12

    (145 days)

    Product Code
    NGT
    Regulation Number
    880.5200
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TK Pre-Filled Normal Saline Flush Syringe

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Pre-Filled Normal Saline Flush Syringe is intended to be used only for the flushing vascular access devices.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device called "TK Pre-Filled Normal Saline Flush Syringe."

    The letter acknowledges the submission of a premarket notification and states that the device is substantially equivalent to legally marketed predicate devices. It also outlines regulatory requirements but does not include details about performance testing, study designs, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot generate the requested table and information based on the given input.

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