📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Use during cardiopulmonary bypass for open-heart surgery requiring extracorporeal circulation.
- Oxygenation of blood during cardiopulmonary bypass.
- Removal of carbon dioxide from blood during cardiopulmonary bypass.
Clinical Applications
- Cardiopulmonary bypass during coronary artery bypass grafting.
- Cardiopulmonary bypass during heart valve repair or replacement.
- Extracorporeal blood-gas exchange during open-heart procedures.
- Temporary support of oxygenation and carbon dioxide removal while the heart and lungs are not performing these functions.
Practical Considerations
- The oxygenator is intended for use by trained cardiac surgical and perfusion teams as part of a compatible cardiopulmonary bypass circuit.
- Proper priming, de-airing, monitoring and anticoagulation are required to reduce the risks of air embolism, clotting and inadequate gas exchange.
- Available configurations or sizes should be selected for the patient's body size, blood-flow requirements and the planned procedure.
- This is an extracorporeal-use device and is not implanted in the patient. MRI safety should not be assumed; the device and complete bypass circuit should be managed according to the manufacturer's labeling and institutional policy.
- Potential complications relate to cardiopulmonary bypass and the oxygenator circuit, including bleeding, clotting, air embolism, blood trauma, inflammation and inadequate oxygen or carbon dioxide exchange.
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.