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510(k) Data Aggregation
K Number
K993245Device Name
CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM
Manufacturer
ALBA CRITICAL CARE LTD
Date Cleared
1999-10-28
(30 days)
Product Code
DYG
Regulation Number
870.1240Why did this record match?
Applicant Name (Manufacturer) :
ALBA CRITICAL CARE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor system's intended use is for the assessment of a patient's 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 allows for sampling of venous blood.
Device Description
The Continuous Cardiac Output Pulmonary Artery Catheter, (catalogue # 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 Continuous Cardiac Output Monitor, (catalogue # TruCCOM), is a microprocessor-based computer which, when interfaced with the TruCATH, continuously calculates and displays cardiac output. The Monitor calculates cardiac output based on the thermodynamic principle of heat transfer using thermal power produced by the thermal 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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