# K971669: Cobe HVR 4000 Filtered and Nonfiltered Hardshell Venous Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Jul 23, 1997 after 78 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) Maxima Hardshell Venous Reservoir - Top Entry, Model MHR-T: named in the summary without a submission number

## Most influential descendants
- K984456: Cobe HVR 4000 Filtered Hardshell Venous Reservoir (1999), 1 descendant of its own
- K990239: Cobe VVR 4000 Filtered Hardshell  Venous Reservoir (1999), 0 descendants of its own

## Indications for use
The HVR 4000 Filtered is intended for storage and filtration of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours. The HVR 4000 Nonfiltered is intended for storage of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.

Source page: https://510kreport.com/device/K971669
Methodology: https://510kreport.com/methodology