K163261 is an FDA 510(k) clearance for the AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by AtriCure, Inc. (Mason, US). The FDA issued a Cleared decision on May 19, 2017, 179 days after receiving the submission on November 21, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K163261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2016 |
| Decision Date | May 19, 2017 |
| Days to Decision | 179 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 |