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510(k) Data Aggregation
K Number
K070384Device Name
ARGON CONTINUOUS FLUSH DEVICE
Manufacturer
Date Cleared
2007-03-29
(48 days)
Product Code
Regulation Number
870.1210Why did this record match?
Applicant Name (Manufacturer) :
ARGON MEDICAL DEVICES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in invasive physiological pressure measurements which require continuous regulated flow to maintain catheter patency.
Device Description
Invasive physiological pressure monitoring requires a number of components that include an IV administration set, a pressure transducer, a monitoring line and a catheter. Because of the potential for clot formation over the course of physiologic monitoring, a continuous flush device can be included in these systems for slow flush of the monitoring line. This minimizes the possibility that blood clots will form within the catheter and at the catheter tip. The Argon Continuous Flush Device is a slow flush device that is intended to be used with the components identified above for slow and continuous flushing of indwelling lines to minimize the formation of clots that would interfere with monitoring integrity.
The Argon Continuous Flush Device is manufactured in two distinct configurations, a 3 ml/hr flow rate device and a 30 ml/hour flow rate device. The design difference which results in continuous flow rates of 3 ml/hr and 30 ml/hr for each of the two models of devices is achieved by the diameter of a laser-drilled flow control orifice in each unit. The orifice diameter is predefined for each version to correlate to the desired output flow rate. The two devices are distinguished from one another by the color of the flush device cap. The 3 ml/hr continuous flush device has a clear cap and the 30 ml/hr continuous flush device has a yellow cap.
Both devices are connected to an IV administration system including a pressurized bag of saline that typically is heparinized. Applied pressure from the bag (300 mmHg) initiates the flow through the IV administration set and the flush device. The slow flow prevents over-infusion, and minimizes clot formation. The "fast flush" feature of the device assists in priming and removing bubbles from the lines or catheters and supplying a fast flow of intravenous fluid to the patient to assess the integrity of the entire monitoring system. This feature is actuated by squeezing the tabs on either side of the device or by pulling up the pull tab on the top of the device.
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