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affinity pixie arterial filter with balance biosurface affinity r pediatric arterial blood filter
Medtronic
Summary: The Affinity Pixie Arterial Filter with Balance Biosurface is a pediatric arterial blood filter used in cardiovascular procedures. It is primarily used by pediatric cardiac surgeons and perfusionists to filter blood during cardiopulmonary bypass.
FDA Clearance Information
Pathway
510K
Number
K251744 ↗
Decision Date
January 16, 2026
Product Code
DTM
Device Class
Class 2
Evidence
0 studies
The Affinity Pixie Arterial Filter was cleared through the FDA 510k pathway on January 16, 2026. Manufactured by Medtronic, it is classified as a Class 2 device under product code DTM.
What It Is
The Affinity Pixie Arterial Filter is a specialized medical device designed to filter out microemboli and other particulate matter from the blood during cardiopulmonary bypass procedures in pediatric patients. It features the Balance Biosurface, which helps reduce protein adsorption and platelet activation, thereby minimizing potential complications during surgery. This device is crucial in maintaining blood purity and preventing embolic events in delicate pediatric cardiovascular surgeries.
Clinical Applications
This arterial filter is commonly used in pediatric cardiac surgeries, particularly during procedures requiring cardiopulmonary bypass. It is utilized in settings such as children's hospitals and specialized cardiac centers. The device is essential for ensuring safe and effective blood filtration in neonates and infants undergoing complex cardiac repairs.
Indications for Use
The FDA-cleared indications for the Affinity Pixie Arterial Filter include its use in filtering blood during cardiopulmonary bypass in pediatric patients. It is specifically designed for use in patients who require extracorporeal circulation support during cardiac surgery.
Practical Considerations
The Affinity Pixie Arterial Filter is designed to be compatible with standard pediatric cardiopulmonary bypass circuits. It is important to ensure proper sizing and integration into the bypass system to optimize filtration efficiency. Clinicians should be familiar with the setup and operation of the filter to ensure optimal performance during procedures.
Frequently Asked Questions
What is the Affinity Pixie Arterial Filter used for?
It is used to filter blood during cardiopulmonary bypass in pediatric cardiac surgeries, removing microemboli and particulate matter.
What specialties typically use this device?
Pediatric cardiac surgeons and perfusionists commonly use this device in specialized cardiac centers and children's hospitals.
What are the FDA-cleared indications?
The device is indicated for filtering blood during cardiopulmonary bypass in pediatric patients, particularly in cardiac surgeries requiring extracorporeal circulation.
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.