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510(k) Data Aggregation

    K Number
    K121511
    Device Name
    MACLIN POWER INTRAVASCULAR ADMINISTRATION SET
    Manufacturer
    Date Cleared
    2013-03-07

    (290 days)

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

    MACLIN POWER INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Maclin Power intravascular administration is a single use, sterile device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
    Device Description
    The Maclin Power Intravascular Administration Sets are devices used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include one or more of the following: tubing, flow regulators, drip chamber, filters, backflow valves, fluid delivery tubing, clamps, connectors between parts of the set, needleless connectors, needleless Y sites, burettes, extension sets, Y tubing connector, protection caps and a hollow spike to connect the tubing to an IV bag or other infusion fluid container. Maclin Power will offer both standard sets and custom sets to meet customer specifications.
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