K191413 is an FDA 510(k) clearance for the AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip. 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 August 21, 2019, 85 days after receiving the submission on May 28, 2019.
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 | K191413 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 2019 |
| Decision Date | August 21, 2019 |
| Days to Decision | 85 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. |