# K181474: ArtiClip LAA Exclusion System

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: Jun 28, 2018 after 24 days
- Product code: PZX (Left Atrial Appendage 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: 14 generations back to K933887 (1993). 69 ancestors in all.
7 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)
- K180010: AtriClip FLEX-V, AtriCure, Inc. (2018) Summary page 4.

## Most influential descendants
- 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
- K220305: Syntheon LAA Exclusion System, Syntheon LAA Selection Guide (2022), 2 descendants of its own
- K233407: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) (2023), 1 descendant of its own
- K232295: LAA Exclusion System (2023), 1 descendant of its own

## 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/K181474
Methodology: https://510kreport.com/methodology