The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Isolator Transpolar Pen System, Models Asu2, Max1, Max2 And Asb1.
| Device ID | K061593 |
| 510k Number | K061593 |
| Device Name: | ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1 |
| 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 C Abruzzo |
| Correspondent | Elsa C Abruzzo ATRICURE, INC. 6033 SCHUMACHER PARK DR. West Chester, OH 45069 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-08 |
| Decision Date | 2006-07-12 |
| Summary: | summary |