PZX — Left Atrial Appendage Clip, Implantable Class II
FDA product code PZX covers "Left Atrial Appendage Clip, Implantable", a Class II medical device regulated under 21 CFR 878.4300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PZX
- Device Class
- Class II
- Regulation Number
- 878.4300
- Submission Type
- Review Panel
- CV
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
Intended to occlude the left atrial appendage.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254232 | edwards lifesciences | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial A | June 26, 2026 |
| K252917 | genesee biomedical | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | May 22, 2026 |
| K243860 | atricure | AtriClip PRO-Mini LAA Exclusion System (PROM) | January 15, 2025 |
| K234125 | atricure | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | July 29, 2024 |
| K233407 | atricure | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); Atri | November 2, 2023 |
| K232295 | syntheon | LAA Exclusion System | August 30, 2023 |
| K220305 | syntheon | Syntheon LAA Exclusion System, Syntheon LAA Selection Guide | October 28, 2022 |
| K210293 | atricure | AtriClip LAA Exclusion System | March 3, 2021 |
| K191413 | atricure | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LA | August 21, 2019 |
| K181474 | atricure | ArtiClip LAA Exclusion System | June 28, 2018 |