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, Atriclip Laa Exclusion System With Preloaded V-clip.
| Device ID | K191413 |
| 510k Number | K191413 |
| Device Name: | AtriClip LAA Exclusion System With Preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System With Preloaded V-Clip |
| Classification | Left Atrial Appendage Clip, Implantable |
| Applicant | AtriCure, Inc 7555 Innovation Way Mason, OH 45040 |
| Contact | Jim Taufen |
| Correspondent | Jim Taufen AtriCure, Inc 7555 Innovation Way Mason, OH 45040 |
| Product Code | PZX |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-28 |
| Decision Date | 2019-08-21 |