ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
Device Facts
| Record ID | K252917 |
|---|---|
| Device Name | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) |
| Applicant | Genesee Biomedical, Inc. |
| Product Code | PZX · General, Plastic Surgery |
| Decision Date | May 22, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
