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510(k) Data Aggregation
K Number
K192289Device Name
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
Manufacturer
IRRAS USA, Ltd.
Date Cleared
2019-11-15
(84 days)
Product Code
JXG, GWM
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
IRRAS USA, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The use of IRRAflow® CNS System is indicated when intracranial pressure monitoring is required and for externally draining intracranial fluid as a means of reducing intracranial pressure in patients where an external drainage and monitoring system is needed.
Device Description
The IRRAflow® CNS System is an intracranial pressure (ICP) monitoring and drainage system. The IRRAflow® CNS System consists of an IRRAflow Control Unit and two sterile disposable parts, the IRRAflow Tube Set and the IRRAflow Catheter. The drainage flow of cerebrospinal fluid (CSF) into the IRRAflow Catheter is uni-directional and gravity-driven; there is no recirculation of the CSF. A parallel line from the saline infusion bag is used in case clearance at the tip of the catheter is required. The IRRAflow Tube Set has a cassette that clicks on to the IRRAflow Control Unit and aligns the tubing against a peristaltic pump and pinch valve. An aspiration bag is attached to the Control Unit tape measure, defining the height of the bag relative to the catheter's tip position in the patient's head and thus controlling the speed of drainage. The tubing and catheter can be disconnected and connected by standard Luer-Lock connectors. Settings can be changed via the user interface on the Control Unit. The default mode provides drainage and measuring ICP, allowing single bolus injections when indicated. The bolus injections allow the catheter to be flushed when it becomes clogged. CSF or intracranial fluid samples can be taken from the aspiration port.
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