The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Coolrail Linear Pen.
| Device ID | K183065 |
| 510k Number | K183065 |
| Device Name: | Coolrail Linear Pen |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 |
| Contact | Caitlin Wunderlin |
| Correspondent | Caitlin Wunderlin AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-05 |
| Decision Date | 2018-12-04 |
| Summary: | summary |