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510(k) Data Aggregation
K Number
K013523Device Name
CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013
Manufacturer
Date Cleared
2002-01-07
(76 days)
Product Code
Regulation Number
880.5440Why 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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