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affinity fusion cardiotomy venous reservoir with balance biosurface
Medtronic
Summary: The Affinity Fusion Cardiotomy Venous Reservoir with Balance Biosurface by Medtronic is a device used in cardiac surgery to collect and filter blood. It is primarily used by cardiovascular surgeons during procedures requiring cardiopulmonary bypass.
FDA Clearance Information
Pathway
510K
Number
K132972 ↗
Decision Date
October 28, 2013
Product Code
DTN
Device Class
Class 2
Evidence
0 studies
The Affinity Fusion Cardiotomy Venous Reservoir was cleared through the FDA 510(k) pathway on October 28, 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 a component of the cardiopulmonary bypass circuit used during cardiac surgery. It collects blood from the surgical field and venous return, filtering and removing air before returning it to the patient. The Balance Biosurface technology helps reduce blood activation and improve biocompatibility, which is crucial during prolonged bypass procedures.
Clinical Applications
This device is commonly used in cardiac surgeries such as coronary artery bypass grafting, valve replacements, and congenital heart defect repairs. It is utilized in operating rooms by cardiovascular surgeons and perfusionists. The device is essential in procedures where maintaining blood volume and minimizing air embolism are critical for patient safety.
Indications for Use
The device is indicated for use in patients undergoing cardiac surgery requiring cardiopulmonary bypass. It is suitable for adult and pediatric patients where blood management and air removal are necessary.
Practical Considerations
The Affinity Fusion Cardiotomy Venous Reservoir is compatible with standard cardiopulmonary bypass systems. It is available in various sizes to accommodate different patient needs. Clinicians should ensure compatibility with other components of the bypass circuit and be familiar with setup and priming techniques to optimize performance.
Frequently Asked Questions
What is the Affinity Fusion Cardiotomy Venous Reservoir used for?
It is used during cardiac surgery to collect and filter blood, ensuring safe and efficient cardiopulmonary bypass.
What specialties typically use this device?
Cardiovascular surgeons and perfusionists in cardiac surgery settings use this device.
What are the FDA-cleared indications?
It is indicated for use in patients undergoing cardiac surgery requiring cardiopulmonary bypass, suitable for both adult and pediatric patients.
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.