K050459 is an FDA 510(k) clearance for the ATRICURE ISOLATOR TRANSPOLAR PEN. 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. (West Chester, US). The FDA issued a Cleared decision on June 13, 2005, 110 days after receiving the submission on February 23, 2005.
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 | K050459 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2005 |
| Decision Date | June 13, 2005 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| 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 |