The following data is part of a premarket notification filed by Atricure Inc. with the FDA for Isolator Multifunctional Linear Pen.
| Device ID | K163408 |
| 510k Number | K163408 |
| Device Name: | Isolator Multifunctional 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 | Melissa Smallwood |
| Correspondent | Melissa Smallwood 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 | 2016-12-05 |
| Decision Date | 2017-01-03 |
| Summary: | summary |