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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
K210293
AtriCure, Inc.
AtriClip LAA Exclusion System
03/03/2021
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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