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cobe smarxt optimin surface modified hollow fiber membrane oxygenator
Cobe Cardiovascular
Summary: The Cobe Smarxt Optimin is a surface modified hollow fiber membrane oxygenator used in cardiopulmonary bypass procedures. It is primarily used by cardiac surgeons and perfusionists to oxygenate blood during surgery.
FDA Clearance Information
Pathway
510K
Number
K013480 ↗
Decision Date
November 16, 2001
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Cobe Smarxt Optimin Oxygenator was cleared through the FDA 510k pathway on November 16, 2001. Manufactured by Cobe Cardiovascular, it is classified as a Class 2 device under product code DTZ.
What It Is
The Cobe Smarxt Optimin is a medical device designed to oxygenate blood during cardiopulmonary bypass procedures. It utilizes a surface modified hollow fiber membrane to facilitate gas exchange, ensuring that blood is adequately oxygenated while carbon dioxide is removed. This device is critical during heart surgeries where the heart is temporarily stopped, and blood circulation is maintained extracorporeally.
Clinical Applications
This oxygenator is commonly used in cardiac surgery settings, particularly during procedures such as coronary artery bypass grafting (CABG) and heart valve replacement. It is utilized by cardiac surgeons and perfusionists in operating rooms equipped for open-heart surgery. The device is suitable for both adult and pediatric patient populations requiring cardiopulmonary support.
Indications for Use
The FDA indications for the Cobe Smarxt Optimin Oxygenator include its use in procedures requiring cardiopulmonary bypass, where it serves to oxygenate blood and remove carbon dioxide. It is intended for patients undergoing surgeries that necessitate extracorporeal circulation.
Practical Considerations
The Cobe Smarxt Optimin is available in various sizes to accommodate different patient needs, from pediatric to adult. It is compatible with standard cardiopulmonary bypass circuits. Clinicians should ensure proper priming and setup to optimize performance and minimize air embolism risk.
Frequently Asked Questions
What is Cobe Smarxt Optimin Oxygenator used for?
It is used to oxygenate blood and remove carbon dioxide during cardiopulmonary bypass procedures in heart surgeries.
What specialties typically use this device?
Cardiac surgeons and perfusionists in the field of cardiothoracic surgery typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in cardiopulmonary bypass procedures to provide oxygenation and carbon dioxide removal.
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.