FDA Product Code
FDA Product Code PZX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4300
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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) | Edwards Lifesciences | 2026-06-26 | Traditional | PDF ↗ |
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | Genesee Biomedical, Inc. | 2026-05-22 | Traditional | PDF ↗ |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | AtriCure, Inc. | 2025-01-15 | Special | PDF ↗ |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | AtriCure, Inc. | 2024-07-29 | Traditional | PDF ↗ |
| 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) | AtriCure, Inc. | 2023-11-02 | Special | PDF ↗ |
| K232295 | LAA Exclusion System | Syntheon, LLC | 2023-08-30 | Special | PDF ↗ |
| K220305 | Syntheon LAA Exclusion System, Syntheon LAA Selection Guide | Syntheon | 2022-10-28 | Traditional | PDF ↗ |
| K210293 | AtriClip LAA Exclusion System | AtriCure, Inc. | 2021-03-03 | Special | PDF ↗ |
| K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip | AtriCure, Inc. | 2019-08-21 | Traditional | PDF ↗ |
| K181474 | ArtiClip LAA Exclusion System | AtriCure, Inc. | 2018-06-28 | Special | PDF ↗ |
Product code PZX · Class II · General, Plastic Surgery. Data: openFDA.