đź“‹ FDA Reference
affinity fusion cardiotomy venous reservior with balance biosurface model bb841 affinity fusion cardiotomy venous rese
Medtronic
Summary: The Affinity Fusion Cardiotomy Venous Reservoir with Balance Biosurface is a medical device used in cardiac surgery to collect and manage blood during procedures. It is primarily used by cardiac surgeons and perfusionists.
FDA Clearance Information
Pathway
510K
Number
K122914 ↗
Decision Date
January 9, 2013
Product Code
DTN
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on January 9, 2013. Manufactured by Medtronic, it is classified as a Class 2 device under product code DTN.
What It Is
The Affinity Fusion Cardiotomy Venous Reservoir is part of a cardiopulmonary bypass circuit. It collects blood from the surgical field and venous return, filtering and de-airing it before returning it to the patient. The Balance Biosurface technology helps reduce blood activation and improve biocompatibility, which is crucial during prolonged surgeries.
Clinical Applications
This device is commonly used in cardiac surgeries requiring cardiopulmonary bypass, such as coronary artery bypass grafting (CABG) and valve replacements. It is utilized in both adult and pediatric cardiac surgery settings. Cardiac surgeons and perfusionists rely on it to ensure efficient blood management during complex procedures.
Indications for Use
The device is indicated for use in patients undergoing cardiac surgery where cardiopulmonary bypass is required. It is designed to manage and process blood during these procedures, ensuring safe and effective circulation.
Practical Considerations
The Affinity Fusion Cardiotomy Venous Reservoir is available in various sizes to accommodate different patient needs. It is compatible with standard cardiopulmonary bypass circuits. Proper setup and priming are essential to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the Affinity Fusion Cardiotomy Venous Reservoir used for?
It is used to collect, filter, and de-air blood during cardiac surgeries involving cardiopulmonary bypass.
What specialties typically use this device?
Cardiac surgeons and perfusionists in cardiac surgery settings use this device.
What are the FDA-cleared indications?
The device is indicated for use in cardiac surgeries requiring cardiopulmonary bypass to manage blood 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.