K233407 is an FDA 510(k) clearance for the AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV). This device is classified as a Left Atrial Appendage Clip, Implantable (Class II - Special Controls, product code PZX).
Submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on November 2, 2023, 28 days after receiving the submission on October 5, 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 | K233407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2023 |
| Decision Date | November 02, 2023 |
| Days to Decision | 28 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. |