The following data is part of a premarket notification filed by Atricure Inc. with the FDA for Atriclip Pro, Pro2, And Pro V Laa Exclusion System Devices With Preloaded Gillinov-cosgrove Clip.
| Device ID | K163261 |
| 510k Number | K163261 |
| Device Name: | AtriClip PRO, PRO2, And PRO V LAA Exclusion System Devices With Preloaded Gillinov-Cosgrove Clip |
| Classification | Clip, Implantable |
| Applicant | ATRICURE INC. 7555 Innovation Way Mason, OH 45040 |
| Contact | Jonathan Mcelwee |
| Correspondent | Jonathan Mcelwee ATRICURE INC. 7555 Innovation Way Mason, OH 45040 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2017-05-19 |
| Summary: | summary |