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510(k) Data Aggregation

    K Number
    K162601
    Device Name
    Infusion Set for Single Use
    Date Cleared
    2017-05-31

    (254 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHINVA ANDE HEALTHCARE APPARATUS CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is indicated for the delivery of fluids from a container to a patient's vascular system.
    Device Description
    The proposed devices are indicated for the gravity infusion of fluids from a container to a patient's vascular system through an IV catheter or infusion needle. . There are ten different models, each a different configuration comprised of various components which may include: protective cap, spike, air filter, drip chamber, precision filter, flexible tube, injection site, roller clamp, flow regulator, pinch clamp and luer lock connector. The devices are provided sterile and are single use.
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