đź“‹ FDA Reference
cobe r cml duo r with smart tm surface modified membrance oxygenator
Cobe Cardiovascular
Summary: The Cobe R CML Duo R with Smart TM is a membrane oxygenator used in cardiopulmonary bypass procedures to oxygenate and remove carbon dioxide from the blood. It is typically used by cardiac surgeons and perfusionists during open-heart surgeries.
FDA Clearance Information
Pathway
510K
Number
K974812 ↗
Decision Date
June 1, 1998
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Cobe R CML Duo R with Smart TM was cleared through the FDA 510(k) pathway on June 1, 1998. Manufactured by Cobe Cardiovascular, it is classified as a Class 2 medical device.
What It Is
The Cobe R CML Duo R with Smart TM is a membrane oxygenator designed to facilitate gas exchange during cardiopulmonary bypass procedures. It features a surface-modified membrane that enhances biocompatibility and reduces the risk of clot formation. This device is integral in maintaining oxygenation and carbon dioxide removal from the blood when the heart and lungs are temporarily non-functional during surgery.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during procedures that require cardiopulmonary bypass such as coronary artery bypass grafting (CABG) or heart valve replacement. It is primarily utilized by cardiac surgeons and perfusionists in hospital operating rooms. The patient population includes those undergoing complex cardiac surgeries where temporary heart and lung support is necessary.
Indications for Use
The Cobe R CML Duo R with Smart TM is indicated for use in patients requiring cardiopulmonary support during open-heart surgery. It is specifically designed for procedures that necessitate extracorporeal circulation to manage oxygenation and carbon dioxide removal.
Practical Considerations
The device is available in various sizes to accommodate different patient needs, from pediatric to adult. It is compatible with standard cardiopulmonary bypass circuits and requires careful handling to ensure optimal performance. Proper priming and de-airing techniques are essential to prevent air embolism during use.
Frequently Asked Questions
What is Cobe R CML Duo R with Smart TM used for?
It is used to oxygenate and remove carbon dioxide from the blood during cardiopulmonary bypass in open-heart surgeries.
What specialties typically use this device?
Cardiac surgeons and perfusionists in the context of cardiac surgery.
What are the FDA-cleared indications?
It is indicated for use in patients requiring cardiopulmonary support during open-heart surgery.
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.