đź“‹ FDA Reference
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Medtronic
Summary: The Affinity NT Oxygenator by Medtronic is used in cardiopulmonary bypass procedures to oxygenate and remove carbon dioxide from the blood. It is typically used by cardiovascular surgeons and perfusionists during open-heart surgeries.
FDA Clearance Information
Pathway
510K
Number
K191029 ↗
Decision Date
May 17, 2019
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity NT Oxygenator received FDA clearance via the 510(k) pathway on May 17, 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 medical device designed for use in cardiopulmonary bypass procedures. It functions by oxygenating the blood and removing carbon dioxide, utilizing hollow fiber technology with plasma-resistant fibers. The device is equipped with Trillium Biosurface to enhance biocompatibility, reducing the risk of clotting and improving patient outcomes during surgery.
Clinical Applications
This oxygenator is commonly used in cardiac surgeries requiring cardiopulmonary bypass, such as coronary artery bypass grafting (CABG) and heart valve repair or replacement. It is primarily utilized in hospital settings, particularly in operating rooms and specialized cardiac surgery centers. The device is suitable for adult patients undergoing complex cardiovascular procedures.
Indications for Use
The FDA indications specify that the Affinity NT Oxygenator is intended for use in procedures requiring extracorporeal circulation and blood oxygenation. It is suitable for patients undergoing cardiac surgeries where temporary cardiopulmonary support is necessary.
Practical Considerations
The Affinity NT Oxygenator is available in various models to accommodate different patient sizes and surgical requirements. It is compatible with standard cardiopulmonary bypass machines and should be used by trained perfusionists. Proper setup and monitoring are crucial to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the Affinity NT Oxygenator used for?
It is used for oxygenating blood and removing carbon dioxide during cardiopulmonary bypass in cardiac surgeries.
What specialties typically use this device?
Cardiovascular surgeons and perfusionists in cardiac surgery settings use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring extracorporeal circulation and blood oxygenation, such as during cardiac 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.