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thermodilution catheter intro kit
Norton Performance Plastics
Summary: The thermodilution catheter intro kit is used for measuring cardiac output and other hemodynamic parameters. It is primarily used by cardiologists and critical care specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K800619 ↗
Decision Date
April 24, 1980
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The thermodilution catheter intro kit by Norton Performance Plastics was cleared via the FDA 510(k) pathway on April 24, 1980. It is classified as a Class 2 device under product code DYB.
What It Is
The thermodilution catheter intro kit is a medical device used to measure cardiac output by injecting a known quantity of cold saline and measuring the temperature change downstream in the pulmonary artery. This technique helps assess heart function and fluid status in critically ill patients. The kit typically includes a catheter, syringe, and other necessary components for the procedure.
Clinical Applications
This device is commonly used in intensive care units and cardiac catheterization labs to monitor cardiac output and other hemodynamic parameters. It is particularly useful in managing patients with heart failure, shock, or undergoing major surgery. Cardiologists, anesthesiologists, and critical care physicians are the primary users of this device.
Indications for Use
The thermodilution catheter is indicated for patients who require precise measurement of cardiac output and hemodynamic status. It is often used in patients with complex cardiovascular conditions or those undergoing major surgical procedures.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies. It is important to ensure compatibility with monitoring equipment and to follow aseptic techniques during insertion to prevent infection.
Frequently Asked Questions
What is the thermodilution catheter intro kit used for?
It is used to measure cardiac output and assess hemodynamic status in critically ill patients.
What specialties typically use this device?
Cardiology, anesthesiology, and critical care medicine specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for measuring cardiac output and hemodynamic parameters in patients requiring detailed cardiovascular assessment.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.