The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Coolrail Linear Pen Model Mcri.
| Device ID | K122611 |
| 510k Number | K122611 |
| Device Name: | COOLRAIL LINEAR PEN MODEL MCRI |
| 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 | Jim Lucky, Rac |
| Correspondent | Jim Lucky, Rac 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 | 2012-08-27 |
| Decision Date | 2012-09-26 |
| Summary: | summary |