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cobe smarxt optima xp surface modified hollow fiber membrane oxygenator
Cobe Cardiovascular
Summary: The Cobe Smarxt Optima XP is a hollow fiber membrane oxygenator used in cardiopulmonary bypass procedures. It is utilized by cardiovascular surgeons and perfusionists to oxygenate blood during surgery.
FDA Clearance Information
Pathway
510K
Number
K000255 ↗
Decision Date
April 25, 2000
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Cobe Smarxt Optima XP was cleared through the FDA 510(k) pathway on April 25, 2000. Manufactured by Cobe Cardiovascular, it is classified as a Class 2 medical device.
What It Is
The Cobe Smarxt Optima XP is a surface-modified hollow fiber membrane oxygenator designed for use in cardiopulmonary bypass procedures. It functions by facilitating the exchange of oxygen and carbon dioxide in the blood, effectively acting as an artificial lung during surgery. The device's hollow fiber technology allows for efficient gas transfer while minimizing blood trauma.
Clinical Applications
This oxygenator is commonly used in cardiac surgeries requiring cardiopulmonary bypass, such as coronary artery bypass grafting (CABG) and heart valve replacement. It is typically employed in operating rooms and specialized cardiac centers, primarily by cardiovascular surgeons and perfusionists. The device is suitable for adult patients undergoing complex cardiac procedures.
Indications for Use
The Cobe Smarxt Optima XP is indicated for use in procedures requiring cardiopulmonary bypass, where temporary blood oxygenation and carbon dioxide removal are necessary. It is intended for patients undergoing cardiac surgery who need extracorporeal circulation support.
Practical Considerations
The device is available in various sizes to accommodate different patient needs and is compatible with standard cardiopulmonary bypass circuits. Clinicians should ensure proper priming and de-airing techniques to optimize performance and patient safety.
Frequently Asked Questions
What is the Cobe Smarxt Optima XP used for?
It is used to oxygenate blood and remove carbon dioxide during cardiopulmonary bypass in cardiac surgeries.
What specialties typically use this device?
Cardiovascular surgeons and perfusionists in cardiac surgery settings use this device.
What are the FDA-cleared indications?
The device is indicated for use in cardiopulmonary bypass procedures requiring temporary blood 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.