510(k) K191413

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip by AtriCure, Inc. — Product Code PZX

K191413 is an FDA 510(k) premarket notification submitted by AtriCure, Inc. for the device "AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip". The FDA issued a decision of Substantially Equivalent on August 21, 2019. The device falls under product code PZX (Left Atrial Appendage Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. AtriCure, Inc. has at least 10 other 510(k) clearances on record.