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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