đź“‹ FDA Reference
mvr venous reservoir bag 800 ml mvr venous reservoir bag 1600 ml mvr venous reservoir bag with cortiva bioactive surface 800 ml mvr venous reservoir bag with cortiva bioactive surface 1600 ml
Medtronic Cardiac Surgery
Summary: The MVR Venous Reservoir Bag is used in cardiac surgery to collect and store venous blood. It is utilized by cardiac surgeons during procedures requiring extracorporeal circulation.
FDA Clearance Information
Pathway
510K
Number
K241053 ↗
Decision Date
May 15, 2024
Product Code
DTN
Device Class
Class 2
Evidence
0 studies
The MVR Venous Reservoir Bag by Medtronic was cleared via the FDA 510k pathway on May 15, 2024. It is a Class 2 device under product code DTN.
What It Is
The MVR Venous Reservoir Bag is a medical device used in cardiac surgeries to collect and store venous blood during extracorporeal circulation. It is available in 800 ml and 1600 ml capacities, with an option for a Cortiva Bioactive Surface to enhance biocompatibility. This device is crucial for maintaining blood volume and pressure during procedures that require cardiopulmonary bypass.
Clinical Applications
This device is commonly used in cardiac surgeries, such as coronary artery bypass grafting (CABG) and valve replacement surgeries. It is typically employed in operating rooms by cardiac surgeons and perfusionists. The reservoir bag is essential for procedures involving cardiopulmonary bypass, where it helps manage blood flow and volume in adult and pediatric patients.
Indications for Use
The MVR Venous Reservoir Bag is indicated for use in patients undergoing cardiac surgery requiring extracorporeal circulation. It is suitable for managing venous blood collection and storage during procedures like CABG and valve surgeries.
Practical Considerations
The MVR Venous Reservoir Bag comes in two sizes, 800 ml and 1600 ml, to accommodate different patient needs and surgical scenarios. The option with Cortiva Bioactive Surface may offer enhanced biocompatibility, reducing the risk of clotting and inflammation. Compatibility with standard extracorporeal circuits should be verified before use.
Frequently Asked Questions
What is the MVR Venous Reservoir Bag used for?
It is used to collect and store venous blood during cardiac surgeries requiring extracorporeal circulation.
What specialties typically use this device?
Cardiac surgeons and perfusionists in the field of cardiac surgery.
What are the FDA-cleared indications?
The device is indicated for use in cardiac surgeries requiring extracorporeal circulation, such as CABG and valve replacement.
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.