# K082082: Gish SVR Soft Venous Reservoirs with HA Coating

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Feb 4, 2009 after 196 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 K955046 (1996). 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)
- K955046: Soft Venous Reservoir, Gish Biomedical, Inc. (1996) Summary page 1.
- K024065: Soft Venous Reservoir (Svrxx) with GBS Coating, Gish Biomedical, Inc. (2003) Summary page 1.

## Indications for use
The Gish Soft Venous Reservoir with HA Coating is indicated for use collecting systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six (6.0) hours.

Source page: https://510kreport.com/device/K082082
Methodology: https://510kreport.com/methodology