Denver, CO, US · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KRH | — | — | — | 4 | 2025-07-25 |
| PZX | Left Atrial Appendage Clip, Implantable | Class II | General, Plastic Surgery | 1 | 2026-05-22 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-22 | K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | PZX | Class II | General, Plastic Surgery |
| 2025-07-25 | K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | KRH | — | — |
| 2024-04-09 | K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | KRH | — | — |
| 2023-05-26 | K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | KRH | — | — |
| 2020-10-06 | K202253 | TruForm Sievers Annuloplasty Ring | KRH | — | — |