# K153500: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Jan 27, 2016 after 51 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.
10 later devices descend from it; 1 cites it directly.
0 of 77 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.

## Most influential descendants
- K173031: AtriClip LAA Exclusion System with Preloaded PRO·V Clip (2017), 9 descendants of its own
- K180010: AtriClip FLEX-V (2018), 8 descendants of its own
- K181474: ArtiClip LAA Exclusion System (2018), 7 descendants of its own
- K191413: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip (2019), 6 descendants of its own
- K210293: AtriClip LAA Exclusion System (2021), 5 descendants of its own

## 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/K153500
Methodology: https://510kreport.com/methodology