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, Gillinov-cosgrove Section Guide Model Various Laa0.
| Device ID | K093679 |
| 510k Number | K093679 |
| Device Name: | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0 |
| Classification | Clip, Implantable |
| Applicant | ATRICURE, INC. 6217 CENTER PARK DRIVE West Chester, OH 45069 |
| Contact | James Lucky |
| Correspondent | James Lucky ATRICURE, INC. 6217 CENTER 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 | 2009-11-27 |
| Decision Date | 2010-06-10 |
| Summary: | summary |