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affinity cp centrifugal bllod pump with carmeda bioactive surface
Medtronic
Summary: The Affinity CP Centrifugal Blood Pump by Medtronic is a medical device used in cardiac surgeries to circulate blood extracorporeally. It is primarily used by cardiac surgeons and perfusionists during procedures requiring cardiopulmonary bypass.
FDA Clearance Information
Pathway
510K
Number
K111658 ↗
Decision Date
June 28, 2011
Product Code
KFM
Device Class
Class 2
Evidence
0 studies
The Affinity CP Centrifugal Blood Pump was cleared through the FDA 510k pathway on June 28, 2011. Manufactured by Medtronic, it is classified as a Class 2 device under product code KFM.
What It Is
The Affinity CP Centrifugal Blood Pump is a device designed to circulate blood outside the body during cardiac surgery. It uses centrifugal force to propel blood, minimizing hemolysis and ensuring smooth flow. The pump is coated with Carmeda BioActive Surface to enhance biocompatibility and reduce the risk of clot formation.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during procedures that require cardiopulmonary bypass, such as coronary artery bypass grafting or heart valve repair/replacement. It is utilized by cardiac surgeons and perfusionists in hospital operating rooms. The pump is suitable for both adult and pediatric patients undergoing complex cardiac procedures.
Indications for Use
The Affinity CP Centrifugal Blood Pump is indicated for use in patients undergoing cardiac surgery that requires extracorporeal circulation. It is particularly beneficial for procedures where maintaining blood flow and minimizing blood trauma are critical.
Practical Considerations
The pump is available in various sizes to accommodate different patient needs and is compatible with standard extracorporeal circuit components. Proper setup and priming are essential to ensure optimal performance and patient safety during use.
Frequently Asked Questions
What is the Affinity CP Centrifugal Blood Pump used for?
It is used to circulate blood extracorporeally during cardiac surgeries requiring cardiopulmonary bypass.
What specialties typically use this device?
Cardiac surgeons and perfusionists in hospital operating rooms typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients undergoing cardiac surgery requiring extracorporeal 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.