# K172742: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: Oct 11, 2017 after 29 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K933887 (1993). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163261: AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip, AtriCure, Inc. (2017) Summary page 4.

## Indications for use
The AtriClip LAA Exclusion System is indicated for the occlusion of the heart’s left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

Source page: https://510kreport.com/device/K172742
Methodology: https://510kreport.com/methodology