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..
List of Left Atrial Appendage Clip, Implantable devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Left Atrial Appendage Clip, Implantable devices (product code PZX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →