The following data is part of a premarket notification filed by Atricure, Inc with the FDA for Isolator Transpolar Pen, Isolator Long Pen Tt, Isolator Linear Pen.
| Device ID | K192125 |
| 510k Number | K192125 |
| Device Name: | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator 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 | Johnathon Mcelwee |
| Correspondent | Kristen Evenson 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 | 2019-08-06 |
| Decision Date | 2019-11-04 |