Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K973334
    Device Name
    OZ POWER SYRINGE
    Manufacturer
    CARDIOVASCULAR INNOVATIONS
    Date Cleared
    1998-04-03

    (211 days)

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

    CARDIOVASCULAR INNOVATIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Injection of contrast media into the heart, great vessels, and coronary arteries, to study the heart and vessels by x-ray photography
    Device Description
    The Oz Power Syringe consists of a 35cc syringe that is manually powered by a lever arm which attaches to a base. As the lever arm is raised, the synnge is titled with the distal tip plyoting on a pin while the plunger filts to a higher angle. The mechanism is designed to stop the plunger as the lever arm is raised to pull the plunger back in the synnge barrel to 35cc. At this position, the lever arm is approximately at a 45 degree angle from the base and the syringe is titled to help produce power as the lever arm will be pushed downward to deliver the contrast media in the syringe. The operator loads the syringe by pulling back on the plunger to draw in the contrast, then pushes the plunger forward to remove air, as is done with a traditional manual syringe. To deliver contrast media, the operator presses down on the lever handle. The operator can easily adjust the delivery pressure in response to fluoroscope or x-ray imaging, or in response to patient comfort levels, by simply adjusting the manual force applied to the lever. The Oz Power Syringe allows the operator to produce more pounds per square inch pressure than normal synnge use. By applying 80-70 pounds of downward pressure on the lever, the operator can easily achieve a 200-350 psl delivery prossure. It is easy to load and inject. It is easy to control and requires much less space than electrically driven power injector equipment. This device enables the operator to produce sufficient pressures to achieve proper contrast delivery, while maintaining control throughout the delivery process. It is very important that the proper amount of contrast media, as well as the pressure and rate at which it is delivered, be controlled for safe and desirable results to both the operator and the patient.
    Ask a Question

    Page 1 of 1