Left Atrial Appendage Clip, Implantable
General, Plastic Surgery · 21 CFR 878.4300
Intended to occlude the left atrial appendage.
Recent MDR events
134 adverse event reports on file
- Penditure LAA Exclusion SystemJul 30, 2026InjurySurgical1219930-2026-04716
- ATRICLIP PRO2® GILLINOV-COSGROVE¿ LAA EXCLUSION SYSTEMMay 28, 2026MalfunctionAtricure, Inc.25315879
- ATRICLIP® LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE® CLIPMay 28, 2026DeathAtricure, Inc.3011706110-2026-00025
- ATRICLIP FLEX-MINI LAA EXCLUSION SYSTEMMay 14, 2026InjuryAtricure, Inc.3011706110-2026-00024
- ATRICLIP® LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE® CLIPMay 12, 2026InjuryAtricure, Inc.3011706110-2026-00023
- ATRICLIP® LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE® CLIPMay 7, 2026InjuryAtricure, Inc.3011706110-2026-00022
- PENDITURE LAA EXCLUSION SYSTEMApr 23, 2026MalfunctionSurgical1219930-2026-02642
- PENDITURE LAA EXCLUSION SYSTEMApr 22, 2026InjurySurgical1219930-2026-02622
- ATRICLIP® PRO-V® LAA EXCLUSION SYSTEMApr 8, 2026InjuryAtricure, Inc.3011706110-2026-00020
- PENDITURE LAA EXCLUSION SYSTEMApr 2, 2026MalfunctionSurgical1219930-2026-02161
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
23 firms currently registered for this product code
Isomedix Operations, Inc.
Libertyville, IL, US
Medtronic Perfusion Systems
Minneapolis, MN, US
Scientific Molding Corporation Ltd. Dba Smc Ltd.
Santa Rosa, CA, US
Isomedix Operations Inc
GROVEPORT, OH, US
Sterigenics Us Llc
Fort Worth, TX, US
Celestica De Monterrey S.a. De C.v.
Apodaca Nuevo Leon, MX
Nutek Bravo, Hayward
Hayward, CA, US
Isomedix Operations Inc.
Sandy, UT, US
Atricure, Inc.
Mason, OH, US
Isomedix Operations, Inc.
Libertyville, IL, US
Edwards Lifesciences Llc
IRVINE, CA, US
510(k) clearances
10 clearances for this product code
- Edwards LifesciencesJun 26, 2026
K254232 · ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)
- Genesee Biomedical, Inc.May 22, 2026
K252917 · ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
- AtriCure, Inc.Jan 15, 2025
K243860 · AtriClip PRO-Mini LAA Exclusion System (PROM)
- AtriCure, Inc.Jul 29, 2024
K234125 · AtriClip FLEX-Mini LAA Exclusion System (ACHM)
- AtriCure, Inc.Nov 2, 2023
K233407 · 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 System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)
- Syntheon, LLCAug 30, 2023
K232295 · LAA Exclusion System
- SyntheonOct 28, 2022
K220305 · Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
- AtriCure, Inc.Mar 3, 2021
K210293 · AtriClip LAA Exclusion System