đź“‹ FDA Reference
affinity af100 arterial filter with balance biosurface
Medtronic
Summary: The Affinity AF100 Arterial Filter with Balance Biosurface is a medical device 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
K122760 ↗
Decision Date
December 7, 2012
Product Code
DTM
Device Class
Class 2
Evidence
0 studies
The Affinity AF100 Arterial Filter was cleared through the FDA 510(k) pathway on December 7, 2012. Manufactured by Medtronic, it is classified as a Class 2 device under product code DTM.
What It Is
The Affinity AF100 Arterial Filter is a component used in extracorporeal circulation systems during cardiac surgery. It is designed to remove air bubbles and particulate matter from the blood, thus reducing the risk of embolic events. The Balance Biosurface technology helps in minimizing protein adsorption and platelet activation, which can enhance biocompatibility and reduce complications during surgery.
Clinical Applications
This arterial filter is commonly used in cardiac surgeries that require cardiopulmonary bypass, such as coronary artery bypass grafting (CABG) and valve replacement surgeries. It is utilized in both adult and pediatric populations to ensure the safety and efficacy of the bypass procedure. Cardiovascular surgeons and perfusionists in hospital surgical settings are the primary users of this device.
Indications for Use
The FDA indications for the Affinity AF100 Arterial Filter involve its use in filtering blood during cardiopulmonary bypass procedures. It is intended for patients undergoing surgeries that require extracorporeal circulation, helping to prevent embolic complications.
Practical Considerations
The Affinity AF100 Arterial Filter is typically compatible with standard cardiopulmonary bypass systems. It is important to ensure proper sizing and integration with the bypass circuit to maintain optimal flow rates and filtration efficiency. Clinicians should be familiar with the setup and operation of the device to maximize its benefits.
Frequently Asked Questions
What is the Affinity AF100 Arterial Filter used for?
It is used in cardiac surgeries to filter out air bubbles and particulates from the blood during cardiopulmonary bypass procedures.
What specialties typically use this device?
Cardiovascular surgeons and perfusionists typically use this device during cardiac surgeries requiring cardiopulmonary bypass.
What are the FDA-cleared indications?
The device is indicated for use in filtering blood during cardiopulmonary bypass procedures to reduce 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.