Product code PZX
- Device name
- Left Atrial Appendage Clip, Implantable
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4300
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Intended to occlude the left atrial appendage.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | Genesee Biomedical, Inc. | 2026-05-22 |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | AtriCure, Inc. | 2025-01-15 |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | AtriCure, Inc. | 2024-07-29 |
| 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 ... | AtriCure, Inc. | 2023-11-02 |
| K232295 | LAA Exclusion System | Syntheon, LLC | 2023-08-30 |
| K220305 | Syntheon LAA Exclusion System, Syntheon LAA Selection Guide | Syntheon | 2022-10-28 |
| K210293 | AtriClip LAA Exclusion System | AtriCure, Inc. | 2021-03-03 |
| K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip | AtriCure, Inc. | 2019-08-21 |
| K181474 | ArtiClip LAA Exclusion System | AtriCure, Inc. | 2018-06-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10840143911781 | AtriClip® FLEX-Mini™ LAA Exclusion System | ATRICURE, INC. | 2024-08-30 |
| 10840143911774 | AtriClip® FLEX-Mini™ LAA Exclusion System | ATRICURE, INC. | 2024-08-30 |
| 10840143906541 | AtriClip FLEX•V | ATRICURE, INC. | 2023-01-06 |
| 10840143906695 | AtriClip FLEX•V | ATRICURE, INC. | 2023-01-06 |
| 10840143906640 | AtriClip FLEX•V | ATRICURE, INC. | 2023-01-06 |
| 10840143906596 | AtriClip FLEX•V | ATRICURE, INC. | 2023-01-06 |
| 10840143907548 | AtriClip® PRO•V™ LAA Exclusion System | ATRICURE, INC. | 2023-01-06 |
| 10840143907593 | AtriClip® PRO•V™ LAA Exclusion System | ATRICURE, INC. | 2023-01-06 |
| 10840143907647 | AtriClip® PRO•V™ LAA Exclusion System | ATRICURE, INC. | 2023-01-06 |
| 10840143907692 | AtriClip® PRO•V™ LAA Exclusion System | ATRICURE, INC. | 2023-01-06 |
| 10840143907470 | AtriClip® LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143906879 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143907418 | AtriClip® LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143907357 | AtriClip® LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143907296 | AtriClip® LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143907210 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143907128 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143907036 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143906947 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143906008 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143906824 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143906770 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143906725 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143906459 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143906381 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143906312 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143906244 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143906183 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143906121 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |
| 10840143906060 | AtriClip™ LAA Exclusion System | ATRICURE, INC. | 2023-01-05 |