# K984456: Cobe HVR 4000 Filtered Hardshell Venous Reservoir

- Pathway: 510(k) (Special)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Jan 11, 1999 after 27 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 K971669 (1997). 1 ancestor in all.
1 later device descends 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)
- K971669: Cobe HVR 4000 Filtered and Nonfiltered Hardshell Venous Reservoir, Cobe Cardiovascular, Inc. (1997) Summary page 1.

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

## Indications for use
The COBE® HVR® 4000 Filtered Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours.

Source page: https://510kreport.com/device/K984456
Methodology: https://510kreport.com/methodology