K234125
- 510(k) number
- K234125
- Device name
- AtriClip FLEX-Mini LAA Exclusion System (ACHM)
- Applicant
- AtriCure, Inc. OH · US
- Product code
- PZX — Left Atrial Appendage Clip, Implantable
- Decision date
- 2024-07-29
- Date received
- 2023-12-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K234125.pdf
Official FDA record: K234125
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.