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affinity pixie arterial filter with balance biosurface
Medtronic
Summary: The Affinity Pixie Arterial Filter with Balance Biosurface is a medical device used to filter blood during cardiovascular procedures. It is primarily used by cardiac surgeons and perfusionists in pediatric and adult cardiac surgeries.
FDA Clearance Information
Pathway
510K
Number
K100646 ↗
Decision Date
December 16, 2010
Product Code
DTM
Device Class
Class 2
Evidence
0 studies
The Affinity Pixie Arterial Filter was cleared through the FDA 510(k) pathway on December 16, 2010. Manufactured by Medtronic, it is classified as a Class 2 device under product code DTM.
What It Is
The Affinity Pixie Arterial Filter is designed to remove air bubbles and particulate matter from the blood during extracorporeal circulation in cardiac surgeries. It features the Balance Biosurface, which helps minimize blood activation and improves biocompatibility. This device is crucial in maintaining blood purity and preventing embolic events during surgery.
Clinical Applications
This arterial filter is commonly used in cardiac surgeries requiring cardiopulmonary bypass, particularly in pediatric and adult patients. It is utilized in settings such as operating rooms and cardiac surgery centers. The device is essential for procedures where maintaining blood integrity and minimizing embolic risk are critical, such as coronary artery bypass grafting (CABG) and valve replacements.
Indications for Use
The device is indicated for use in filtering blood during extracorporeal circulation in cardiac surgeries. It is suitable for patients undergoing procedures that require cardiopulmonary bypass, helping to ensure the removal of air and particulates from the blood.
Practical Considerations
The Affinity Pixie Arterial Filter is available in various sizes to accommodate different patient populations, including pediatric patients. It is compatible with standard extracorporeal circulation systems. Clinicians should ensure proper integration with the bypass circuit and monitor for any potential clogs or flow restrictions during use.
Frequently Asked Questions
What is the Affinity Pixie Arterial Filter used for?
It is used to filter blood during cardiac surgeries, removing air bubbles and particulates to prevent embolic events.
What specialties typically use this device?
Cardiac surgeons and perfusionists primarily use this device during cardiopulmonary bypass procedures.
What are the FDA-cleared indications?
The device is indicated for filtering blood during extracorporeal circulation in cardiac surgeries to ensure the removal of air and particulates.
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.