Left Atrial Appendage Clip, Implantable
FDA product code PZX · Class II (moderate risk) · 21 CFR 878.4300 · General, Plastic Surgery
Intended to occlude the left atrial appendage.
10510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…PZX · Traditional | Edwards Lifesciences | 06/26/2026SE |
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD)PZX · Traditional | Genesee Biomedical, Inc. | 05/22/2026SE |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM)PZX · Special | AtriCure, Inc. | 01/15/2025SE |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM)PZX · Traditional | AtriCure, Inc. | 07/29/2024SE |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…PZX · Special | AtriCure, Inc. | 11/02/2023SE |
| K232295 | LAA Exclusion SystemPZX · Special | Syntheon, LLC | 08/30/2023SE |
| K220305 | Syntheon LAA Exclusion System, Syntheon LAA Selection GuidePZX · Traditional | Syntheon | 10/28/2022SE |
| K210293 | AtriClip LAA Exclusion SystemPZX · Special | AtriCure, Inc. | 03/03/2021SE |
| K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…PZX · Traditional | AtriCure, Inc. | 08/21/2019SE |
| K181474 | ArtiClip LAA Exclusion SystemPZX · Special | AtriCure, Inc. | 06/28/2018SE |