# K030077: Gish Tubing and Connectors with GBS Coating

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Mar 14, 2003 after 65 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) Gish Tubing and Connectors: named in the summary without a submission number

## Most influential descendants
- K092486: Vortex Medical Angiovac Cardiopulmonary Bypass Circuit (2009), 1 descendant of its own
- K142607: AngioVac Circuit (2014), 0 descendants of its own

## Indications for use
The Gish Tubing and Connectors with GBSTMCoating are indicated for use in Surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit. It is designed to operate at flow rates of one (1.O) to six (6.0) liters per minute for periods up to six (6) hours.

Source page: https://510kreport.com/device/K030077
Methodology: https://510kreport.com/methodology