The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Bipolar System, Models Asu1, Asu2, Asu3, Lhp1, Lhp2, Rhp1.
| Device ID | K020919 |
| 510k Number | K020919 |
| Device Name: | ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-21 |
| Decision Date | 2002-04-19 |
| Summary: | summary |