đź“‹ FDA Reference
affinity af100 arterial filter with carmeda bioactive surface
Medtronic Perfusion Systems
Summary: The Affinity AF100 Arterial Filter with Carmeda BioActive Surface is used in cardiac surgery to filter out emboli and other particulates from the blood. It is primarily used by cardiac surgeons and perfusionists during cardiopulmonary bypass procedures.
FDA Clearance Information
Pathway
510K
Number
K123351 ↗
Decision Date
March 19, 2013
Product Code
DTM
Device Class
Class 2
Evidence
0 studies
The Affinity AF100 Arterial Filter was cleared through the FDA 510(k) pathway on March 19, 2013. It is manufactured by Medtronic Perfusion Systems and is classified as a Class 2 device under product code DTM.
What It Is
The Affinity AF100 Arterial Filter is a medical device used during cardiopulmonary bypass procedures to remove air bubbles and particulate matter from the blood. It features the Carmeda BioActive Surface, which helps reduce the risk of thrombosis by mimicking the natural endothelial surface. This filter is an essential component in maintaining blood purity and ensuring patient safety during complex cardiac surgeries.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during procedures that require cardiopulmonary bypass, such as coronary artery bypass grafting (CABG) and valve replacement surgeries. It is utilized by cardiac surgeons and perfusionists to ensure that the blood being circulated outside the body is free from potentially harmful emboli and particulates. The filter is crucial in preventing complications that can arise from embolic events during surgery.
Indications for Use
The FDA indications for the Affinity AF100 Arterial Filter include its use in filtering blood during cardiopulmonary bypass procedures. It is intended for patients undergoing cardiac surgeries where blood filtration is necessary to prevent embolic complications.
Practical Considerations
The Affinity AF100 Arterial Filter is designed to be compatible with standard cardiopulmonary bypass circuits. Clinicians should ensure proper sizing and integration into the bypass system to optimize performance. Familiarity with the device's setup and operation is essential for effective use during surgery.
Frequently Asked Questions
What is the Affinity AF100 Arterial Filter used for?
It is used to filter out air bubbles and particulates from the blood during cardiopulmonary bypass procedures in cardiac surgery.
What specialties typically use this device?
Cardiac surgeons and perfusionists typically use this device during cardiac surgeries requiring cardiopulmonary bypass.
What are the FDA-cleared indications?
It is indicated for use in filtering blood during cardiopulmonary bypass procedures 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.