K232295 is an FDA 510(k) clearance for the LAA Exclusion System. This device is classified as a Left Atrial Appendage Clip, Implantable (Class II - Special Controls, product code PZX).
Submitted by Syntheon, LLC (Miami, US). The FDA issued a Cleared decision on August 30, 2023, 29 days after receiving the submission on August 1, 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 | K232295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2023 |
| Decision Date | August 30, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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. |