# K033641: Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir, Model 439914800

- Pathway: 510(k) (Special)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Dec 11, 2003 after 21 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) COBE Cardiovascular® VVR 4000 Filtered Hardshell Venous Reservoir: named in the summary without a submission number

## Indications for use
The COBE Cardiovascular® SMARxT® VVR TM 4000i Plus Filtered Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours, and for postoperative chest drainage collection and autotransfasion.

Source page: https://510kreport.com/device/K033641
Methodology: https://510kreport.com/methodology