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Affinity Fusion Cardiotomy Venous Reservior with Balance Biosurface Model BB841 Affinity Fusion Cardiotomy Venous Rese
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 ?
510(k)
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.
FDA-Cleared Indications
- Use during cardiac surgical procedures requiring cardiopulmonary bypass.
- Collect, filter, and manage cardiotomy blood and venous return within a cardiopulmonary bypass circuit.
- Support blood handling and de-airing during extracorporeal circulation.
Clinical Applications
- Cardiopulmonary bypass during coronary artery bypass grafting.
- Cardiopulmonary bypass during cardiac valve repair or replacement.
- Collection and filtration of blood from the operative field during open cardiac surgery.
- Management of venous blood drainage and air removal within the bypass circuit.
Practical Considerations
- This is a single-use component intended for integration with a compatible cardiopulmonary bypass circuit.
- The reservoir must be correctly assembled, primed, monitored, and operated by trained cardiac surgical and perfusion personnel.
- Available configurations or sizes should be selected according to the circuit design, blood-flow requirements, and patient population.
- The device is used outside the body in an extracorporeal circuit; it is not an implant and is not intended for direct placement in a blood vessel.
- MRI safety labeling should be confirmed in the current manufacturer instructions; an extracorporeal bypass circuit should not be taken into an MRI environment unless specifically evaluated and permitted.
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.