# K004046: Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered Hardshell Venous Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Apr 26, 2001 after 118 days
- Product code: DTP (Defoamer, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4230
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K092315: Sorin VVR 4000I and 4000I Smarxt Filtered Hardshell Venous Reservoir (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K004046
Methodology: https://510kreport.com/methodology