The following data is part of a premarket notification filed by Medwaves, Inc. with the FDA for Avecure Bt Microwave Ablation System.
| Device ID | K192406 |
| 510k Number | K192406 |
| Device Name: | AveCure BT Microwave Ablation System |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | MedWaves, Inc. 16760 West Bernardo Drive San Diego, CA 92127 |
| Contact | Theodore Ormsby |
| Correspondent | Theodore Ormsby MedWaves, Inc. 16760 West Bernardo Drive San Diego, CA 92127 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2020-11-25 |