AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip
FDA 510(k) clearance K191413 · decided 2019-08-21
Clearance details
- K-number
- K191413
- Device name
- AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip
- Applicant
- AtriCure, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-28
- Decision date
- 2019-08-21
- Days to decision
- 85 days
- Clearance type
- Traditional
- 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
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |