The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Ablation System.
| Device ID | K063630 |
| 510k Number | K063630 |
| Device Name: | ATRICURE ABLATION SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ATRICURE, INC. 6033 SCHUMACHER PARK DR. West Chester, OH 45069 |
| Contact | Elsa C Abruzzo |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-12-06 |
| Decision Date | 2007-01-26 |
| Summary: | summary |