510(k) K163261

AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip by AtriCure, Inc. — Product Code FZP

K163261 is an FDA 510(k) premarket notification submitted by AtriCure, Inc. for the device "AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip". The FDA issued a decision of Substantially Equivalent on May 19, 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.