# K220305: Syntheon LAA Exclusion System, Syntheon LAA Selection Guide

- Pathway: 510(k) (Traditional)
- Applicant: Syntheon
- Decided: Oct 28, 2022 after 268 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: 17 generations back to K933887 (1993). 72 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210293: AtriClip LAA Exclusion System, AtriCure, Inc. (2021) Summary page 4.

## Most influential descendants
- K232295: LAA Exclusion System (2023), 1 descendant of its own
- K252917: ATLAAS (Atraumatic Left Atrial Appendage System) (AD) (2026), 0 descendants of its own

## Indications for use
The Syntheon LAA Exclusion System is indicated for the exclusion 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 any other appropriate viewing technology.

Source page: https://510kreport.com/device/K220305
Methodology: https://510kreport.com/methodology