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510(k) Data Aggregation

    K Number
    K112734
    Device Name
    APLAN A.V. FISTULA NEEDLE SET
    Manufacturer
    APLAN WELL ENTERPRISE CO., LTD
    Date Cleared
    2012-04-24

    (217 days)

    Product Code
    FIE
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    APLAN WELL ENTERPRISE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A.V. Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device is intended for single use only.
    Device Description
    A.V. Fistula Needle Set is a single-use fistula needle which is inserted for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device consists of a needle that is attached to wings, a flexible tube and a luer lock connector.
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