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510(k) Data Aggregation

    K Number
    K132905
    Device Name
    200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER
    Manufacturer
    ARTERIOCYTE MEDICAL SYSTEMS, INC.
    Date Cleared
    2013-10-04

    (18 days)

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

    ARTERIOCYTE MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 200 Micron Blood Component Filter and Syringe Adapter is designed to filter clots and other particles from blood and blood components for delivery.
    Device Description
    Tubing assembly with a 200 micron filter connected by tubing with clamp and luer on one end and a purchased piston syringe on the other end.
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