K180010 is an FDA 510(k) clearance for the AtriClip FLEX-V. 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 January 31, 2018, 29 days after receiving the submission on January 2, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K180010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2018 |
| Decision Date | January 31, 2018 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |