# K241053: 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

- Pathway: 510(k) (Special)
- Applicant: Medtronic Cardiac Surgery
- Decided: May 15, 2024 after 28 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920774 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920774: MVR Collapsible Venous Reservoir Bag, Medtronic Vascular (1992) Summary page 5.

## Indications for use
The MVR Venous Reservoir Bag is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator for up to 6 hours in duration. The MVR Holder (Model MVR-SH) is indicated for use with the MVR Collapsible Venous Reservoir Bag.

Source page: https://510kreport.com/device/K241053
Methodology: https://510kreport.com/methodology