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)
FDA 510(k) clearance K233407 · decided 2023-11-02
Clearance details
- K-number
- K233407
- Device name
- 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)
- Applicant
- AtriCure, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-10-05
- Decision date
- 2023-11-02
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- PZX
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mason, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch AtriCure
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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) (K254232) | Edwards Lifesciences | 2026-06-26 |
| ATLAAS (Atraumatic Left Atrial Appendage System) (AD) (K252917) | Genesee Biomedical, Inc. | 2026-05-22 |
| AtriClip PRO-Mini LAA Exclusion System (PROM) (K243860) | AtriCure, Inc. | 2025-01-15 |
| AtriClip FLEX-Mini LAA Exclusion System (ACHM) (K234125) | AtriCure, Inc. | 2024-07-29 |
| LAA Exclusion System (K232295) | Syntheon, LLC | 2023-08-30 |
| Syntheon LAA Exclusion System, Syntheon LAA Selection Guide (K220305) | Syntheon | 2022-10-28 |
| AtriClip LAA Exclusion System (K210293) | AtriCure, Inc. | 2021-03-03 |
| AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip (K191413) | AtriCure, Inc. | 2019-08-21 |
| ArtiClip LAA Exclusion System (K181474) | AtriCure, Inc. | 2018-06-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| EPi-Sense ST Coagulation System (P200002/S013) | AtriCure, Inc. | 2025-11-14 |
| EPi-Sense Guided Coagulation System (P200002/S012) | AtriCure, Inc. | 2025-10-07 |
| Synergy Ablation System (P100046/S019) | AtriCure, Inc. | 2025-06-17 |
| EPi-Sense Guided Coagulation System (P200002/S011) | AtriCure, Inc. | 2025-06-17 |
| EPi-Sense and EPi-Sense ST Guided Coagulation System (P200002/S010) | AtriCure, Inc. | 2025-03-03 |
| Cannula with Guide (P200002/S009) | AtriCure, Inc. | 2024-08-28 |
| Synergy Ablation System (P100046/S018) | AtriCure, Inc. | 2024-03-15 |
| EPi-Sense Guided Coagulation System and EPi-Sense ST Coagulation System (P200002/S008) | AtriCure, Inc. | 2023-12-11 |