# K964067: Gore Irrigation Set

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Jun 5, 1997 after 238 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 no predicate by number.

## Indications for use
Like other, commercially available vascular irrigation sets and intravascular administration sets, the GORE irrigation system is intended to irrigate vascular tissue intraoperatively. This includes use of the GORE irrigation system to infuse sterile irrigant solution into a vein to allow visualization of the valve destruction process during vein preparation for in-situ vascular bypass

Source page: https://510kreport.com/device/K964067
Methodology: https://510kreport.com/methodology