📋 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 ?
510(k)
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.
FDA-Cleared Indications
- For use during cardiac surgical procedures requiring extracorporeal circulation.
- For collection and temporary storage of venous blood within an extracorporeal blood circuit.
- For use as part of a cardiopulmonary bypass or other extracorporeal circulation circuit when configured according to the applicable instructions for use.
Clinical Applications
- Venous blood collection during coronary artery bypass grafting performed with cardiopulmonary bypass.
- Venous blood collection during cardiac valve repair or replacement requiring extracorporeal circulation.
- Temporary blood-volume management during open cardiac surgery using an extracorporeal circuit.
- Use by the cardiac surgical and perfusion teams as a reservoir component of an extracorporeal circulation system.
Practical Considerations
- Models are available in nominal capacities of 800 mL and 1600 mL; the appropriate size depends on the circuit configuration and clinical requirements.
- Confirm that the reservoir connections, tubing, connectors and other circuit components are compatible before use.
- The device is intended for use by trained cardiac surgical and perfusion personnel in an operating-room extracorporeal circulation setting.
- Cortiva Bioactive Surface models should be selected and handled according to their specific labeling; the surface does not replace standard anticoagulation and circuit-management protocols.
- This is not an implanted device. MRI conditions are generally not relevant while the reservoir is outside the patient, but the applicable product labeling should be reviewed if any component is present near an MRI environment.
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.