The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Isolator Linear Pen.
| Device ID | K130521 |
| 510k Number | K130521 |
| Device Name: | ISOLATOR LINEAR PEN |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | ATRICURE, INC. 6217 CENTRE PARK DRIVE West Chester, OH 45069 |
| Contact | Rebecca Walters |
| Correspondent | Rebecca Walters ATRICURE, INC. 6217 CENTRE PARK DRIVE West Chester, OH 45069 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-28 |
| Decision Date | 2013-04-05 |
| Summary: | summary |