# K993001: Cobe Smarxt HVR 4000 Surface Modified Hardshell Venous Reservoir, Filtered & Nonfiltered

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Dec 3, 1999 after 87 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® HVR® 4000™ Filtered Hardshell Venous Reservoir: named in the summary without a submission number

## Indications for use
The COBE® SMAR,T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoirs are intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours.

Source page: https://510kreport.com/device/K993001
Methodology: https://510kreport.com/methodology