510(k) clearance
ACHM30 AtriClip FLEX-Mini LAA Exclusion System
- 510(k) number
- K263319
- Applicant
- AtriCure, Inc.
- Decision date
- Oct 21, 2026
- Date received
- Sep 21, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- PZX
- Device type
- Left Atrial Appendage Clip, Implantable
- Device class
- Class II
- Regulation
- 21 CFR 878.4300
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Mason, OH, US