K220305 is an FDA 510(k) clearance for the Syntheon LAA Exclusion System, Syntheon LAA Selection Guide. This device is classified as a Left Atrial Appendage Clip, Implantable (Class II - Special Controls, product code PZX).
Submitted by Syntheon (Miami, US). The FDA issued a Cleared decision on October 28, 2022, 268 days after receiving the submission on February 2, 2022.
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 | K220305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2022 |
| Decision Date | October 28, 2022 |
| Days to Decision | 268 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. |