The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atriclip Laa Exclusion System With Preloaded Gillinov-cosgrove Pro V Clip.
| Device ID | K153500 |
| 510k Number | K153500 |
| Device Name: | AtriClip LAA Exclusion System With Preloaded Gillinov-Cosgrove PRO V Clip |
| Classification | Clip, Implantable |
| Applicant | Atricure, Inc. 6217 Centre Park Drive West Chester, OH 45069 |
| Contact | Jonathan Mcelwee |
| Correspondent | Jonathan Mcelwee Atricure, Inc. 6217 Centre Park Drive West Chester, OH 45069 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-07 |
| Decision Date | 2016-01-27 |
| Summary: | summary |