# K023833: Gish Arterial Filter with GBS Coating

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Mar 31, 2003 after 133 days
- Product code: DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line)
- Device class: 2
- Regulation: 21 CFR 870.4260
- 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 K914791 (1993). 1 ancestor in all.
1 later device descends 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)
- K914791: Gish Arterial Filter, Gish Biomedical, Inc. (1993) Summary page 1.

## Most influential descendants
- K081054: Gish Arterial Filter with HA Coating (2009), 0 descendants of its own

## Indications for use
The GlSH arterial filters are indicated for use in the extracorporeal bypass circuit for the removal of microemboli. It is designed to operate at flow rates of one (1 .O) to six (6.0) liters per minute for periods up to six (6.0) hours.

Source page: https://510kreport.com/device/K023833
Methodology: https://510kreport.com/methodology