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510(k) Data Aggregation

    K Number
    K210929
    Device Name
    MagiCath II
    Date Cleared
    2022-09-13

    (533 days)

    Product Code
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Woo Young Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MagiCath II is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for general patient with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
    Device Description
    MagiCath II, safety IV catheter is inserted into the patient's blood vessel for short-term use to collect blood, monitor blood pressure, or inject drugs. It consists of an over-the-needle, catheter made of radiopaque polyurethane with a passive safety shielding mechanism that will engage upon needle removal from the patient in order to prevent accidental needlestick injuries. The device is available in 18, 20, 22 and 24-gauge catheter. MagiCath II is designed to allow users handling the device with single-hand, using the MagiGrip. In the MagiGrip, a vent fitting to regulate blood flow is placed. The needle hub is equipped with a vent filter which suppresses blood leakage, so the flashback can be more visible.
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