Panels › General, Plastic Surgery › Product code PZX · Class 2
Left Atrial Appendage Clip, Implantable
Regulation 878.4300
3510(k)s in 12 months (11 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PZX
| Company | 510(k)s | Recalls |
|---|---|---|
| AtriCure, Inc. | 7 | 0 |
| Syntheon | 2 | 0 |
| Edwards Lifesciences | 1 | 0 |
| Genesee Biomedical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2026 | K263319 | ACHM30 AtriClip FLEX-Mini LAA Exclusion System AtriCure, Inc. | PZX |
| Jun 26, 2026 | K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLI Edwards Lifesciences | PZX |
| May 22, 2026 | K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) Genesee Biomedical, Inc. | PZX |
| Jan 15, 2025 | K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) AtriCure, Inc. | PZX |
| Jul 29, 2024 | K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) AtriCure, Inc. | PZX |
| Nov 2, 2023 | K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded AtriCure, Inc. | PZX |
| Aug 30, 2023 | K232295 | LAA Exclusion System Syntheon, LLC | PZX |
| Oct 28, 2022 | K220305 | Syntheon LAA Exclusion System, Syntheon LAA Selection Guide Syntheon | PZX |
| Mar 3, 2021 | K210293 | AtriClip LAA Exclusion System AtriCure, Inc. | PZX |
| Aug 21, 2019 | K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip AtriCure, Inc. | PZX |
| Jun 28, 2018 | K181474 | ArtiClip LAA Exclusion System AtriCure, Inc. | PZX |
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