# K081881: Gish Tubing and Connectors with HA Coating

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Jan 23, 2009 after 205 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- 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) Gish Tubing and Connectors: named in the summary without a submission number

## Indications for use
The Gish Tubing and Connectors with HA Coating 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 0) to six (6) liters per minute for periods up to six (6) hours

Source page: https://510kreport.com/device/K081881
Methodology: https://510kreport.com/methodology