đź“‹ FDA Reference
affinity 38 micon arterial filter with trillium biopassive surface model 351t
Medtronic Perfusion Systems
Summary: The Affinity 38 Micon Arterial Filter with Trillium Biopassive Surface is a medical device used in cardiac surgery to filter emboli from the blood. It is primarily used by cardiac surgeons and perfusionists during cardiopulmonary bypass procedures.
FDA Clearance Information
Pathway
510K
Number
K013084 ↗
Decision Date
September 27, 2001
Product Code
DTM
Device Class
Class 2
Evidence
0 studies
The Affinity 38 Micon Arterial Filter was cleared through the FDA 510k pathway on September 27, 2001. Manufactured by Medtronic Perfusion Systems, it is classified as a Class 2 device.
What It Is
The Affinity 38 Micon Arterial Filter is designed to remove air bubbles and particulate matter from the blood during cardiopulmonary bypass. It features a Trillium Biopassive Surface that minimizes protein adsorption and platelet activation, enhancing biocompatibility. This filter is crucial in maintaining blood purity and preventing embolic events during cardiac surgeries.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during procedures involving cardiopulmonary bypass such as coronary artery bypass grafting (CABG) and valve replacements. It is utilized by cardiac surgeons and perfusionists to ensure that the blood returning to the patient is free of potentially harmful emboli. The filter is suitable for use in both adult and pediatric populations undergoing cardiac surgery.
Indications for Use
The FDA indications for the Affinity 38 Micon Arterial Filter include 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 complications.
Practical Considerations
The Affinity 38 Micon Arterial Filter is typically compatible with standard cardiopulmonary bypass circuits. Clinicians should ensure proper integration into the bypass setup and verify compatibility with other components. The device is available in sizes suitable for both adult and pediatric patients.
Frequently Asked Questions
What is the Affinity 38 Micon Arterial Filter used for?
It is used to filter air bubbles and particulate matter from the blood during cardiopulmonary bypass in cardiac surgeries.
What specialties typically use this device?
Cardiac surgeons and perfusionists primarily use this device during cardiac surgeries involving cardiopulmonary bypass.
What are the FDA-cleared indications?
The device 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.