# K081054: Gish Arterial Filter with HA Coating

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Jan 15, 2009 after 276 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: 2 generations back to K914791 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
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.
- K023833: Gish Arterial Filter with GBS Coating, Gish Biomedical, Inc. (2003) Summary page 1.

## Indications for use
The Arterial Filter with HA Coating is indicated for use for up to 6 hours in the extracorporeal bypass circuit for the removal of microemboli.

Source page: https://510kreport.com/device/K081054
Methodology: https://510kreport.com/methodology