# K050195: V-Bag with GBS Coating

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Mar 17, 2005 after 49 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001822: The V-Bag, Circulatory Technology, Inc. (2000) Summary page 2.
- K024065: Soft Venous Reservoir (Svrxx) with GBS Coating, Gish Biomedical, Inc. (2003) Summary page 1.

## Indications for use
The Circulatory Technology Inc. V-BAG with GBS® Coating is a disposable soft shell venous reservoir that accepts venous and cardiotomy blood and facilitates the removal of air bubbles during surgical procedures requiring extracorporeal support for up to six hours. When used with the Vac-Box, it can be used for Vacuum Assisted Venous Drainage (VAVD).

Source page: https://510kreport.com/device/K050195
Methodology: https://510kreport.com/methodology