The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Bipolar Coagulation System.
| Device ID | K011722 |
| 510k Number | K011722 |
| Device Name: | ATRICURE BIPOLAR COAGULATION SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ATRICURE, INC. 6033 SCHUMACHER PARK DR. West Chester, OH 45069 |
| Contact | Mark L Friedman |
| Correspondent | Mark L Friedman ATRICURE, INC. 6033 SCHUMACHER PARK DR. West Chester, OH 45069 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-04 |
| Decision Date | 2001-08-30 |
| Summary: | summary |