đź“‹ FDA Reference
affinity nt oxygenator with balance biosurface affinity nt oxygenator with balance biosurface and uncoated cardiotomy venous reservoir
Medtronic
Summary: The Affinity NT Oxygenator with Balance Biosurface 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 during open-heart surgeries.
FDA Clearance Information
Pathway
510K
Number
K191444 ↗
Decision Date
September 27, 2019
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity NT Oxygenator was cleared through the FDA 510(k) pathway on September 27, 2019. Manufactured by Medtronic, it is classified as a Class 2 device under product code DTZ.
What It Is
The Affinity NT Oxygenator is a device designed to replace the function of the lungs during cardiopulmonary bypass procedures. It oxygenates the blood and removes carbon dioxide, ensuring that the patient's tissues receive adequate oxygenation during surgery. The Balance Biosurface coating helps reduce the risk of clotting and inflammation, enhancing biocompatibility.
Clinical Applications
This oxygenator is commonly used in cardiac surgeries, such as coronary artery bypass grafting (CABG) and valve replacements, where cardiopulmonary bypass is required. It is utilized in operating rooms and specialized cardiac centers, primarily by cardiac surgeons and perfusionists. The device is suitable for a wide range of patients, including adults and pediatric populations undergoing heart surgery.
Indications for Use
The FDA-cleared indications for the Affinity NT Oxygenator include its use in procedures requiring cardiopulmonary bypass, where temporary blood oxygenation and carbon dioxide removal are necessary. It is intended for patients undergoing open-heart surgery.
Practical Considerations
The Affinity NT Oxygenator is available in various sizes to accommodate different patient needs. It is compatible with standard cardiopulmonary bypass circuits. Clinicians should be familiar with the setup and operation of the device to ensure optimal performance during procedures.
Frequently Asked Questions
What is Affinity NT Oxygenator used for?
It is used to oxygenate and remove carbon dioxide from the blood during cardiopulmonary bypass in open-heart surgeries.
What specialties typically use this device?
Cardiac surgery teams, including cardiac surgeons and perfusionists, typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in cardiopulmonary bypass procedures requiring temporary blood oxygenation and carbon dioxide removal during open-heart surgery.
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.