đź“‹ FDA Reference
affinity nt oxygenator and uncoated cardiotomy venous reservoir 541 affinity nt oxygenator with balance biosurface and uncoated cardiotomy venous reservoir 541b
Medtronic
Summary: The Affinity NT Oxygenator is a medical device used in cardiopulmonary bypass procedures to oxygenate and remove carbon dioxide from the blood. It is primarily used by cardiac surgeons and perfusionists in operating rooms.
FDA Clearance Information
Pathway
510K
Number
K241352 ↗
Decision Date
June 12, 2024
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity NT Oxygenator, manufactured by Medtronic, was cleared through the FDA 510k pathway on June 12, 2024. It is classified as a Class 2 device under product code DTZ.
What It Is
The Affinity NT Oxygenator is a critical component in cardiopulmonary bypass circuits, designed to oxygenate blood and remove carbon dioxide during cardiac surgery. It functions by mimicking the gas exchange process of the lungs, allowing for the temporary replacement of pulmonary function. This device is essential in procedures where the heart and lungs need to be bypassed, ensuring the patient's blood remains oxygenated.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during procedures such as coronary artery bypass grafting (CABG) and heart valve repair or replacement. It is utilized by cardiac surgeons and perfusionists in hospital operating rooms. The device is suitable for adult patients undergoing open-heart surgery, where maintaining adequate oxygenation and carbon dioxide removal is critical.
Indications for Use
The Affinity NT Oxygenator is indicated for use in patients requiring cardiopulmonary bypass during cardiac surgery. It is designed to support patients who need their heart and lung function temporarily replaced during complex surgical procedures.
Practical Considerations
The device is available in various sizes to accommodate different patient body sizes and blood flow requirements. It is compatible with standard cardiopulmonary bypass circuits and should be used by trained professionals familiar with extracorporeal circulation techniques.
Frequently Asked Questions
What is the Affinity NT Oxygenator used for?
It is used to oxygenate blood and remove carbon dioxide during cardiopulmonary bypass in cardiac surgery.
What specialties typically use this device?
Cardiac surgeons and perfusionists typically use this device in operating room settings.
What are the FDA-cleared indications?
It is indicated for use in patients undergoing cardiopulmonary bypass during cardiac surgery to support heart and lung function.
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.