đź“‹ FDA Reference
affinity pixie oxygenator with balance biosurface affinity pixie oxygenator with cardiotomy venous reservoir and balance biosurface affinity pixie oxygenator with cortiva bioactive surface affinity fusion oxygenator with cardiotomy venous reservoir and cortiva bioactive surface
Medtronic
Summary: The Affinity Pixie 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
K172984 ↗
Decision Date
November 20, 2017
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity Pixie Oxygenator by Medtronic was cleared via the FDA 510k pathway on November 20, 2017. It is classified as a Class 2 device under product code DTZ.
What It Is
The Affinity Pixie Oxygenator is a component of the cardiopulmonary bypass circuit, designed to oxygenate blood and remove carbon dioxide during cardiac surgery. It features Balance Biosurface and Cortiva Bioactive Surface technologies to enhance biocompatibility and reduce inflammatory response. The device is crucial in maintaining adequate gas exchange and blood flow during procedures where the heart and lungs are temporarily bypassed.
Clinical Applications
This device is commonly used in pediatric and adult cardiac surgeries requiring cardiopulmonary bypass, such as valve replacements or congenital heart defect repairs. It is utilized in hospital operating rooms by cardiac surgeons and perfusionists. The device is particularly valuable in settings where precise control of blood oxygenation and carbon dioxide removal is critical.
Indications for Use
The Affinity Pixie Oxygenator is indicated for use in patients undergoing cardiopulmonary bypass procedures. It is suitable for a range of cardiac surgeries where temporary support of the heart and lungs is necessary.
Practical Considerations
The device is available in various sizes to accommodate different patient populations, including pediatric and adult patients. It is compatible with standard cardiopulmonary bypass systems and requires careful handling to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the Affinity Pixie Oxygenator used for?
It is used to oxygenate blood and remove carbon dioxide during cardiopulmonary bypass procedures in cardiac surgeries.
What specialties typically use this device?
Cardiac surgeons and perfusionists in the field of cardiac surgery typically use this device.
What are the FDA-cleared indications?
It is indicated for use in cardiopulmonary bypass procedures during cardiac surgeries.
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.