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The Pulsion Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor are intended for use with the Pulsion PiCCO Cardiac Output System for the measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. The Pulsion PiCCO Cardiac Output System with Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line sensor is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, cardiac, and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.

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I am sorry, but based on the provided document, there is no information about acceptance criteria for a device, a study proving it meets acceptance criteria, or any details related to AI, machine learning, or algorithms.

The document is a US FDA 510(k) clearance letter for the "Pulsion Pulsiocath Thermodilution Catheters and Accessories". It primarily focuses on:

• Device Name: Pulsion Pulsiocath Thermodilution Catheters and Accessories
• Regulation Number & Name: 21 CFR 870.1915, Thermodilution Probe
• Regulatory Class: Class II
• Product Code: KRB
• Date of Clearance: September 19, 2007
• Purpose: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
• Intended Use: For use with the Pulsion PiCCO Cardiac Output System for the measurement of cardiac output by thermodilution method, arterial blood pressure, and cardiac output determination by arterial pulse contour analysis. Indicated for patients requiring cardiovascular and circulatory volume status monitoring.

Therefore, I cannot provide the requested information because it is not present in the given text.

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