The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Isolator Transpolar Pen.
| Device ID | K050459 |
| 510k Number | K050459 |
| Device Name: | ATRICURE ISOLATOR TRANSPOLAR PEN |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | ATRICURE, INC. 6033 SCHUMACHER PARK DR. West Chester, OH 45069 |
| Contact | Elsa Abruzzo |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-02-23 |
| Decision Date | 2005-06-13 |
| Summary: | summary |