AtriClip FLEX-Mini LAA Exclusion System (ACHM)
Device Facts
| Record ID | K234125 |
|---|---|
| Device Name | AtriClip FLEX-Mini LAA Exclusion System (ACHM) |
| Applicant | AtriCure, Inc. |
| Product Code | PZX · General, Plastic Surgery |
| Decision Date | Jul 29, 2024 |
| 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.
