# K024065: Soft Venous Reservoir (Svrxx) with GBS Coating

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Mar 5, 2003 after 86 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 K955046 (1996). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 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.

## Most influential descendants
- K082082: Gish SVR Soft Venous Reservoirs with HA Coating (2009), 0 descendants of its own
- K050195: V-Bag with GBS Coating (2005), 0 descendants of its own

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

Source page: https://510kreport.com/device/K024065
Methodology: https://510kreport.com/methodology