The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atriclip Laa Exclusion System.
| Device ID | K210293 |
| 510k Number | K210293 |
| Device Name: | AtriClip LAA Exclusion System |
| Classification | Left Atrial Appendage Clip, Implantable |
| Applicant | AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 |
| Contact | Mary Galeano |
| Correspondent | Mary Galeano AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 |
| Product Code | PZX |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-02 |
| Decision Date | 2021-03-03 |