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510(k) Data Aggregation
K Number
K081776Device Name
CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM
Manufacturer
OMEGA CRITICAL CARE LIMITED
Date Cleared
2008-07-22
(29 days)
Product Code
DXG
Regulation Number
870.1435Why did this record match?
Applicant Name (Manufacturer) :
OMEGA CRITICAL CARE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor systems intended use is for the assessment of a patients haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also all ws for sampling of venous blood.
Device Description
The Continuous Cardiac Ouptut Pulmonary Artery Catheter, (truCATH), is a six lumen heparin coated, polyvinyl chloride (PVC) flow directed Pulmonary Artery Catheter. Once placed the proximal extensions of the catheter are attached to the second part of the system, the monitor. The Continous Cardiac Output Monitor, (truCCOM), is a microprocessor based computer which when interfaced with the truCATH, continuously calculates and displays cardiac output. The monitor calculates cardiac output based upon a thermodynamic principle of heat transfer using thermal power produced by the termal coil area on the Catheter. Alternatively the monitor can also be used by the clinician to measure cardiac output intermittently through using the injectate capabilities of the catheter.
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