📋 FDA Reference
Affinity Cp Centrifugal Bllod Pump with Carmeda Bioactive Surface
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 ?
510(k)
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.
FDA-Cleared Indications
- For use during procedures requiring extracorporeal circulation.
- For pumping blood through an extracorporeal circuit during cardiac surgery.
- For use with compatible cardiopulmonary bypass equipment according to the device labeling and instructions for use.
Clinical Applications
- Cardiopulmonary bypass during coronary artery bypass grafting.
- Cardiopulmonary bypass during heart valve repair or replacement.
- Extracorporeal circulation during other open cardiac surgical procedures.
- Blood circulation through a compatible extracorporeal circuit in adult or pediatric cardiac surgery, when specified by the applicable labeling.
Practical Considerations
- The pump is used by trained perfusionists and cardiac operating-room teams as part of a properly assembled, primed, and monitored extracorporeal circuit.
- Compatible circuit components, tubing, connectors, console, and flow-monitoring equipment must be selected according to the applicable instructions for use.
- Available configurations or sizes should be matched to the patient, circuit flow requirements, and institution-approved perfusion protocols.
- This is an external blood-contacting device and requires appropriate anticoagulation, sterile handling, monitoring, and management of air, pressure, flow, and clot risk.
- The pump should not be assumed to be MRI safe; MRI compatibility depends on the complete pump system, console, circuit, and accessories. Consult current manufacturer labeling before MRI exposure.
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.