# K150996: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: Jun 17, 2015 after 63 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: 13 generations back to K933887 (1993). 68 ancestors in all.
No later device cites it as a predicate yet.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093679: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide  Model Various LAA0, AtriCure, Inc. (2010) Summary page 4.
- K122276: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, AtriCure, Inc. (2012) Summary page 4.
- K131107: Atriclip Gillinov-Cosgrove Laa Clip, AtriCure, Inc. (2013) Summary page 4.
- K142120: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, AtriCure, Inc. (2014) Summary page 4.

## 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/K150996
Methodology: https://510kreport.com/methodology