PZX · Class II · 21 CFR 878.4300

FDA Product Code PZX: Left Atrial Appendage Clip, Implantable

Left atrial appendage occlusion reduces stroke risk in patients with atrial fibrillation who cannot take anticoagulants. FDA product code PZX covers implantable left atrial appendage clips.

These devices are applied epicardially to mechanically occlude the left atrial appendage from the outside of the heart, preventing thrombus formation in this common site of embolic stroke in AF patients. They represent an alternative to catheter-based endovascular LAA closure.

PZX devices are Class II medical devices, regulated under 21 CFR 878.4300 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include AtriCure, Inc., Syntheon and Syntheon, LLC.

9
Total
9
Cleared
107d
Avg days
2018
Since
Stable submission activity - 3 submissions in the last 2 years
Review times increasing: avg 165d recently vs 77d historically

FDA 510(k) Cleared Left Atrial Appendage Clip, Implantable Devices (Product Code PZX)

9 devices
1–9 of 9
Cleared May 22, 2026
ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
K252917
Genesee Biomedical, Inc.
Cardiovascular · 252d
Cleared Jan 15, 2025
AtriClip PRO-Mini LAA Exclusion System (PROM)
K243860
AtriCure, Inc.
Cardiovascular · 30d
Cleared Jul 29, 2024
AtriClip FLEX-Mini LAA Exclusion System (ACHM)
K234125
AtriCure, Inc.
Cardiovascular · 214d
Cleared Nov 02, 2023
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0)
K233407
AtriCure, Inc.
Cardiovascular · 28d
Cleared Aug 30, 2023
LAA Exclusion System
K232295
Syntheon, LLC
Cardiovascular · 29d
Cleared Oct 28, 2022
Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
K220305
Syntheon
Cardiovascular · 268d
Cleared Mar 03, 2021
AtriClip LAA Exclusion System
K210293
AtriCure, Inc.
Cardiovascular · 29d
Cleared Aug 21, 2019
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip
K191413
AtriCure, Inc.
Cardiovascular · 85d
Cleared Jun 28, 2018
ArtiClip LAA Exclusion System
K181474
AtriCure, Inc.
Cardiovascular · 24d

About Product Code PZX - Regulatory Context

510(k) Submission Activity

9 total 510(k) submissions under product code PZX since 2018, with 9 receiving FDA clearance (average review time: 107 days).

Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.

FDA 510(k) Review Time - PZX Product Code

Recent submissions under PZX have taken an average of 165 days to reach a decision - up from 77 days historically. Manufacturers should account for longer review timelines in current project planning.

PZX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →