K234125 is an FDA 510(k) clearance for the AtriClip FLEX-Mini LAA Exclusion System (ACHM). This device is classified as a Left Atrial Appendage Clip, Implantable (Class II - Special Controls, product code PZX).
Submitted by AtriCure, Inc. (Mason, US). The FDA issued a Cleared decision on July 29, 2024, 214 days after receiving the submission on December 28, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 878.4300. Intended To Occlude The Left Atrial Appendage..
| 510(k) Number | K234125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2023 |
| Decision Date | July 29, 2024 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PZX — Left Atrial Appendage Clip, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |
| Definition | Intended To Occlude The Left Atrial Appendage. |