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affinity nt oxygenator with cortiva bioactive surface
Medtronic
Summary: The Affinity NT Oxygenator with Cortiva Bioactive Surface is a medical device used for oxygenating blood during cardiac surgery. It is typically used by cardiac surgeons and perfusionists.
FDA Clearance Information
Pathway
510K
Number
K162016 ↗
Decision Date
September 21, 2016
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity NT Oxygenator with Cortiva Bioactive Surface was cleared via the FDA 510(k) pathway on September 21, 2016. It is manufactured by Medtronic and is classified as a Class 2 device under product code DTZ.
What It Is
The Affinity NT Oxygenator with Cortiva Bioactive Surface is a device used in cardiopulmonary bypass procedures to oxygenate and remove carbon dioxide from the blood. It features a bioactive surface designed to enhance biocompatibility and reduce inflammatory responses. This device is integral to maintaining appropriate blood gas levels during cardiac surgeries, ensuring patient stability.
Clinical Applications
This oxygenator is commonly used in cardiac surgery settings, particularly during procedures that require cardiopulmonary bypass, such as coronary artery bypass grafting or heart valve repair. It is typically used in operating rooms by cardiac surgeons and perfusionists. The device is suitable for both adult and pediatric patients undergoing complex cardiac procedures.
Indications for Use
The device is indicated for use in patients undergoing procedures that require cardiopulmonary bypass, where blood oxygenation and carbon dioxide removal are necessary. It is suitable for patients with conditions necessitating cardiac surgery.
Practical Considerations
The Affinity NT Oxygenator is available in various sizes to accommodate different patient needs. It is compatible with standard cardiopulmonary bypass equipment. Clinicians should ensure proper setup and priming to optimize device performance during surgery.
Frequently Asked Questions
What is the Affinity NT Oxygenator with Cortiva Bioactive Surface used for?
It is used for oxygenating blood and removing carbon dioxide during cardiopulmonary bypass in cardiac surgeries.
What specialties typically use this device?
Cardiac surgeons and perfusionists in operating room settings typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients undergoing cardiopulmonary bypass procedures requiring blood oxygenation and carbon dioxide removal.
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.