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affinity 20u arterial filter with trillium biosurface
Medtronic Perfusion Systems
Summary: The Affinity 20u Arterial Filter with Trillium Biosurface is used in cardiac surgery to filter out emboli and other particulates from the blood. It is primarily used by cardiovascular surgeons and perfusionists during cardiopulmonary bypass procedures.
FDA Clearance Information
Pathway
510K
Number
K033468 ↗
Decision Date
November 14, 2003
Product Code
DTM
Device Class
Class 2
Evidence
0 studies
The Affinity 20u Arterial Filter was cleared via the FDA 510k pathway on November 14, 2003. It is manufactured by Medtronic Perfusion Systems and classified as a Class 2 device.
What It Is
The Affinity 20u Arterial Filter is a medical device used during cardiopulmonary bypass procedures to remove air bubbles, clots, and other particulates from the blood. It features Trillium Biosurface, a coating designed to reduce thrombogenicity and enhance biocompatibility. This device helps ensure that filtered blood is safely returned to the patient, minimizing the risk of embolic events during surgery.
Clinical Applications
This arterial filter is commonly used in cardiac surgeries requiring cardiopulmonary bypass, such as coronary artery bypass grafting (CABG) and valve replacement surgeries. It is typically employed in operating rooms by cardiovascular surgeons and perfusionists. The device is crucial in maintaining blood purity and preventing complications related to emboli in patients undergoing complex cardiac procedures.
Indications for Use
The FDA indications for this device involve its use in filtering blood during cardiopulmonary bypass procedures. It is intended for patients undergoing cardiac surgery where blood filtration is necessary to prevent embolic events.
Practical Considerations
The Affinity 20u Arterial Filter is available in various sizes to accommodate different patient needs and surgical settings. It is compatible with standard cardiopulmonary bypass circuits. Clinicians should ensure proper integration with the bypass system and verify the device's compatibility with other components used during surgery.
Frequently Asked Questions
What is Affinity 20u Arterial Filter used for?
It is used to filter blood during cardiopulmonary bypass procedures, removing air bubbles and particulates to prevent embolic events.
What specialties typically use this device?
Cardiovascular surgeons and perfusionists commonly use this device during cardiac surgeries requiring cardiopulmonary bypass.
What are the FDA-cleared indications?
The device is indicated for filtering blood during cardiopulmonary bypass in cardiac surgeries to prevent embolic complications.
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.