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affinity fusion oxygenator with balance biosurface affinity fusion oxygenator with cardiotomy venous reservoir and balance biosurface affinity fusion oxygenator with cortiva biosurface affinity fusion oxygenator with cortiva bioactive surface cardiotomy venous reservoir
Medtronic
Summary: The Affinity Fusion Oxygenator by Medtronic is a device used in cardiopulmonary bypass procedures. It is FDA 510k cleared and has been evaluated in 6 studies, though specific clinical outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K172626 ↗
Decision Date
October 25, 2017
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity Fusion Oxygenator was cleared by the FDA through the 510k pathway on October 25, 2017. It is manufactured by Medtronic and classified as a Class 2 medical device.
What It Is
The Affinity Fusion Oxygenator is designed for use in cardiopulmonary bypass procedures, providing oxygenation and carbon dioxide removal from the blood. It is intended for use in patients undergoing cardiac surgery.
Clinical Applications
This device is commonly used in cardiac surgeries requiring cardiopulmonary bypass, such as coronary artery bypass grafting and heart valve repair or replacement. It helps maintain blood oxygenation during these procedures.
Evidence Summary
The literature includes 6 studies, though none directly evaluate the Affinity Fusion Oxygenator. The studies range from 2014 to 2025 and include various research types, but specific clinical outcomes related to this device are not detailed.
Reported Outcomes
Published studies report limited direct evidence on the efficacy of the Affinity Fusion Oxygenator. The available studies do not provide specific data on clinical outcomes related to its use in cardiac surgery.
Safety Profile
Reported complications include limited safety data specific to the Affinity Fusion Oxygenator. The studies do not provide detailed adverse event information related to this device.
Evidence Limitations
The evidence base lacks direct studies evaluating the Affinity Fusion Oxygenator's clinical outcomes and safety. Further research is needed to establish its efficacy and safety profile in cardiac surgery settings.
Frequently Asked Questions
What are the clinical indications for Affinity Fusion Oxygenator?
The device is indicated for use in cardiopulmonary bypass procedures during cardiac surgery.
What outcomes have been reported in clinical studies?
Specific outcomes related to the Affinity Fusion Oxygenator are not detailed in the available studies.
What complications have been reported?
Safety data specific to the Affinity Fusion Oxygenator is limited, with no detailed adverse events reported in the studies.
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.