FDA 510(k) Applications for Medical Device Product Code "PZX"

FDA 510(k) Number Applicant Device Name Decision Date
K191413 AtriCure, Inc AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip 08/21/2019
K181474 AtriCure, Inc. ArtiClip LAA Exclusion System 06/28/2018
K234125 AtriCure, Inc. AtriClip FLEX-Mini LAA Exclusion System (ACHM) 07/29/2024
K210293 AtriCure, Inc. AtriClip LAA Exclusion System 03/03/2021
K233407 AtriCure, Inc. AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion Syst 11/02/2023
K243860 AtriCure, Inc. AtriClip PRO-Mini LAA Exclusion System (PROM) 01/15/2025
K220305 Syntheon Syntheon LAA Exclusion System, Syntheon LAA Selection Guide 10/28/2022
K232295 Syntheon, LLC LAA Exclusion System 08/30/2023


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