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510(k) Data Aggregation

    K Number
    K013523
    Device Name
    CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013
    Date Cleared
    2002-01-07

    (76 days)

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

    SHIRE BIOLOGICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To transfer and mix drugs contained in two containers into a syringe for administration to the patient.
    Device Description
    CIStem™ is a closed reconstitution and instillation system used to deliver reconstituted drug through a catheter. This closed system is designed to prevent leakage and prevent exposure of drug to the environment, and is easy to use. The syringe is inserted into the syringe socket of the device and the drug container is inserted into the other socket. A stopcock is used to direct and control the flow between the syringe, drug container and catheter. The syringe plunger rod is pushed to deliver liquid into the drug container. Next the plunger rod is pulled back and forth until all of the drug is mixed. Then the reconstituted drug in the syringe is delivered through the catheter. There are two variations of CIStem™. These variations provide flexibility for the type of drug container. They both have the same intended use and similar safety features. The materials that make up the fluid contact path in CIStem™ have passed ISO 10993-1 biocompatibility testing.
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