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 Clip.
| Device ID | K122276 |
| 510k Number | K122276 |
| Device Name: | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP |
| Classification | Clip, Implantable |
| Applicant | ATRICURE, INC. 6217 CENTRE PARK DRIVE West Chester, OH 45069 |
| Contact | James Lucky |
| Correspondent | James Lucky ATRICURE, INC. 6217 CENTRE PARK DRIVE West Chester, OH 45069 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-30 |
| Decision Date | 2012-08-29 |
| Summary: | summary |