K190151 is an FDA 510(k) clearance for the COBRA Fusion Ablation System. This device is classified as a Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (Class II - Special Controls, product code OCL).
Submitted by AtriCure, Inc. (Mason, US). The FDA issued a Cleared decision on February 25, 2019, 26 days after receiving the submission on January 30, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 878.4400. Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue.
| 510(k) Number | K190151 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2019 |
| Decision Date | February 25, 2019 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | OCL — Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |