# K160454: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: Mar 18, 2016 after 29 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 2 (0 Class I)
- 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)
- K122276: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, AtriCure, Inc. (2012) Summary page 4.

## Recalls of this device
- Nov 30, 2016 · Class II · Z-1148-2017: A complaint of the PRO2 jaw breaking prior to surgery being performed.
- Sep 22, 2016 · Class II · Z-0377-2017: There is a potential for a component failure of the device which could necessitate medical intervention.

## Indications for use
The AtriClip® LAA Exclusion System is indicated for the occlusion of the heart’s left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).

Source page: https://510kreport.com/device/K160454
Methodology: https://510kreport.com/methodology