PZX
- Product code
- PZX
- Device name
- Left Atrial Appendage Clip, Implantable
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4300
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 10 (all years; only the last 3 years are listed here)
FDA classification definition
Intended to occlude the left atrial appendage.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254232 | 2026-06-26 | Edwards Lifesciences | ECLIPTIS Left Atrial Appendage Exclusion System (ECS… | |
| K252917 | 2026-05-22 | Genesee Biomedical, Inc. | ATLAAS (Atraumatic Left Atrial Appendage System) (AD… | |
| K243860 | 2025-01-15 | AtriCure, Inc. | AtriClip PRO-Mini LAA Exclusion System (PROM) | |
| K234125 | 2024-07-29 | AtriCure, Inc. | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | FDA |
| K233407 | 2023-11-02 | AtriCure, Inc. | AtriClip LAA Exclusion System with preloaded Gillino… |
Official FDA classification page: PZX
Classification and pathway per current FDA publications. Data from openFDA (CC0).