510(k) K172742

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) by AtriCure, Inc. — Product Code FZP

K172742 is an FDA 510(k) premarket notification submitted by AtriCure, Inc. for the device "AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)". The FDA issued a decision of Substantially Equivalent on Oct 11, 2017. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. AtriCure, Inc. has 58 other 510(k) clearances on record.