The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atriclip Laa Exclusion System With Preloaded Pro·v Clip.
| Device ID | K173031 |
| 510k Number | K173031 |
| Device Name: | AtriClip LAA Exclusion System With Preloaded PRO·V Clip |
| Classification | Clip, Implantable |
| Applicant | AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 |
| Contact | Melissa Smallwood |
| Correspondent | Melissa Smallwood AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2017-10-25 |
| Summary: | summary |