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510(k) Data Aggregation

    K Number
    K984231
    Device Name
    ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
    Manufacturer
    INVASATEC
    Date Cleared
    2000-05-31

    (553 days)

    Product Code
    DXT, NOV
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVASATEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acist™ CMS-2000 Angiographic Injection System with Contrast Management is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
    Device Description
    The ACIST Medical Systems Angiographic Contrast Management System is an accessory to the ACIST Injection System. It is designed to allow the user to safely use contrast media for multiple procedures . It consists of a two-park kit—Parts A, a non-patient contact kit, and B, a patient contact kit. Part A is initially set up and filled with contrast media. Part B is then attached to Part A via a connector and the system is ready to initiate a procedure. " The Drish attached it Part R VILLE Collection of the procedure, Part B is disconnected and discarded. The syringe cap is placed on Part A to maintain sterility between procedures. The Angiographic Contrast Management System is provided sterile and is intended for single use only.
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    K Number
    K963982
    Device Name
    ACIST ANGIOGRAPHIC INJECTOR
    Manufacturer
    INVASATEC
    Date Cleared
    1997-12-05

    (429 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVASATEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACIST System from Invasatec is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
    Device Description
    The ACIST is an angiographic injector system which supplies radiographic contrast material to a catheter at a clinician determined variable flow rate which can be remotely and continuously varied by the user. The system includes a motorized syringe pump which delivers radiographic contrast material to tubing which is connected to a angiographic catheter. The clinician controls the flow rate of radiographic contrast material from the pump to the catheter with a hand actuated proportional controller. By operating the hand control, the user can vary a command signal in order to adjust the flow rate of radiographic contrast material from the pump to the outlet during the operation of the pump. The remote hand control allows the clinician to interactively adjust flow rate (and thus volume of material delivered to the patient) while observing the angiographic procedure (for example on a fluoroscope monitor). The system also includes a specifically designed disposable kit. The kit includes a syringe and valve assembly, injection manifold assembly, high pressure assembly, tubing assembly and associated caps and connectors. The kit is intended to provide all components necessary to perform an angiographic study.
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