The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atriclip Flex-v.
| Device ID | K180010 |
| 510k Number | K180010 |
| Device Name: | AtriClip FLEX-V |
| Classification | Clip, Implantable |
| Applicant | AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 |
| Contact | Brittany Lowe |
| Correspondent | Brittany Lowe AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-02 |
| Decision Date | 2018-01-31 |
| Summary: | summary |