# K232295: LAA Exclusion System

- Pathway: 510(k) (Special)
- Applicant: Syntheon, LLC
- Decided: Aug 30, 2023 after 29 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: 18 generations back to K933887 (1993). 73 ancestors in all.
1 later device descends 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)
- K220305: Syntheon LAA Exclusion System, Syntheon LAA Selection Guide, Syntheon (2022) Summary page 4.

## Most influential descendants
- K252917: ATLAAS (Atraumatic Left Atrial Appendage System) (AD) (2026), 0 descendants of its own

## Indications for use
The 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/K232295
Methodology: https://510kreport.com/methodology