The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Articlip Laa Exclusion System.
| Device ID | K181474 |
| 510k Number | K181474 |
| Device Name: | ArtiClip LAA Exclusion System |
| Classification | Left Atrial Appendage Clip, Implantable |
| Applicant | AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 |
| Contact | Jonathan Mcelwee |
| Correspondent | Jonathan Mcelwee 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 | 2018-06-04 |
| Decision Date | 2018-06-28 |
| Summary: | summary |