The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Cobra Fusion Ablation System.
| Device ID | K190151 |
| 510k Number | K190151 |
| Device Name: | COBRA Fusion Ablation System |
| 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 | 2019-01-30 |
| Decision Date | 2019-02-25 |
| Summary: | summary |