đź“‹ FDA Reference
malleable single stage venous cannula with carmeda bioactive surface model cb681xx series
Medtronic Perfusion Systems
Summary: The malleable single stage venous cannula with Carmeda bioactive surface is a device used in surgical procedures to facilitate venous access. It is primarily used by cardiovascular surgeons during cardiopulmonary bypass.
FDA Clearance Information
Pathway
510K
Number
K033264 ↗
Decision Date
October 31, 2003
Product Code
DWF
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on October 31, 2003. It is manufactured by Medtronic Perfusion Systems and classified as a Class 2 medical device.
What It Is
The malleable single stage venous cannula is designed for use in cardiopulmonary bypass procedures. It features a Carmeda bioactive surface that reduces thrombogenicity, enhancing blood compatibility. The device is malleable, allowing for easy insertion and positioning within the venous system during surgery.
Clinical Applications
This device is commonly used in cardiac surgery, particularly during procedures requiring cardiopulmonary bypass such as coronary artery bypass grafting (CABG) or valve replacement. It is used in hospital operating rooms by cardiovascular surgeons and perfusionists to ensure efficient venous drainage and blood flow management.
Indications for Use
The FDA indications suggest this device is intended for use in patients undergoing procedures that require cardiopulmonary bypass. It is suitable for patients needing temporary venous access during cardiac surgeries.
Practical Considerations
The cannula is available in various sizes to accommodate different patient anatomies. It is compatible with standard cardiopulmonary bypass equipment. Proper insertion technique is crucial to prevent complications such as air embolism or vessel injury.
Frequently Asked Questions
What is the malleable single stage venous cannula used for?
It is used to facilitate venous access during cardiopulmonary bypass in cardiac surgeries.
What specialties typically use this device?
Cardiovascular surgery and perfusion medicine.
What are the FDA-cleared indications?
The device is indicated for use in cardiopulmonary bypass procedures, providing venous access during cardiac surgeries.
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.