# K092315: Sorin VVR 4000I and 4000I Smarxt Filtered Hardshell Venous Reservoir

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Aug 12, 2009 after 13 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 K004046 (2001). 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)
- K004046: Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Cardiovascular, Inc. (2001) Summary page 1.

## Indications for use
Sorin WR 4000i and Sorin WR 4000i SMARxT filtered hardshell reservoirs are intended to be used in surgical procedures requiring cardiopulmonary bypass for periods up to six hours.

Source page: https://510kreport.com/device/K092315
Methodology: https://510kreport.com/methodology