K153500 is an FDA 510(k) clearance for the AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on January 27, 2016, 51 days after receiving the submission on December 7, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K153500 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2015 |
| Decision Date | January 27, 2016 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZP — Clip, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |