# K990239: Cobe VVR 4000 Filtered Hardshell  Venous Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: May 25, 1999 after 120 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: 2 generations back to K971669 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984456: Cobe HVR 4000 Filtered Hardshell Venous Reservoir, Cobe Cardiovascular, Inc. (1999) Summary page 2.
- (no number) Baxter/Bentley BMR-4500G Filtered Venous Reservoir: named in the summary without a submission number
- (no number) Baxter/Bentley HSR-4000 Filtered Venous Reservoir: named in the summary without a submission number

## Indications for use
The COBE® VVR 4000™ 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 autotransfusion.

Source page: https://510kreport.com/device/K990239
Methodology: https://510kreport.com/methodology