FDA product code PZX: Left Atrial Appendage Clip, Implantable
PZX is the FDA product code for left atrial appendage clip, implantable. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the Cardiovascular panel. FDA has cleared 10 510(k) submissions under PZX, 7 in the last five years, from 5 different applicants. The average 510(k) review took 114 days (median 58); 153 days on average over the last three years.
Definition
Intended to occlude the left atrial appendage.
Classification
| Field | Value |
|---|---|
| Device name | Left Atrial Appendage Clip, Implantable |
| Device class | Class II |
| Regulation | 21 CFR 878.4300 |
| Review panel | CV — Cardiovascular |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PZX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 24 |
| 2019 | 1 | 85 |
| 2021 | 1 | 29 |
| 2022 | 1 | 268 |
| 2023 | 2 | 28 |
| 2024 | 1 | 214 |
| 2025 | 1 | 30 |
| 2026 | 2 | 216 |
Compare with all 510(k) review times · Search every PZX clearance
Top PZX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| AtriCure, Inc. | 6 | 2025-01-15 |
| Edwards Lifesciences | 1 | 2026-06-26 |
| Genesee Biomedical, Inc. | 1 | 2026-05-22 |
| Syntheon, LLC | 1 | 2023-08-30 |
| Syntheon | 1 | 2022-10-28 |
Most recent PZX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254232 | Edwards Lifesciences | 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) | 2026-06-26 | 179 |
| K252917 | Genesee Biomedical, Inc. | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | 2026-05-22 | 252 |
| K243860 | AtriCure, Inc. | AtriClip PRO-Mini LAA Exclusion System (PROM) | 2025-01-15 | 30 |
| K234125 | AtriCure, Inc. | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | 2024-07-29 | 214 |
| K233407 | AtriCure, Inc. | 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) | 2023-11-02 | 28 |
Recalls for PZX devices
openFDA lists no recalls for product code PZX.
Frequently asked questions
What is FDA product code PZX?
PZX is the FDA product code for left atrial appendage clip, implantable. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the Cardiovascular panel.
What device class is PZX?
Class II, regulation 21 CFR 878.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code PZX?
Across 10 cleared submissions the average was 114 days from receipt to decision (median 58).
Which companies have the most PZX clearances?
AtriCure, Inc. (6); Edwards Lifesciences (1); Genesee Biomedical, Inc. (1); Syntheon, LLC (1); Syntheon (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PZX
- Run a recall and safety report across every PZX manufacturer
- Watch product code PZX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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