The following data is part of a premarket notification filed by Vivant Medical, Inc. with the FDA for Vivawave Microwave Ablation System, Coaxial Introducer.
| Device ID | K050223 |
| 510k Number | K050223 |
| Device Name: | VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VIVANT MEDICAL, INC. 1916-A OLD MIDDLEFIELD WAY Mountain View, CA 94043 |
| Contact | Kristine Foss |
| Correspondent | Kristine Foss VIVANT MEDICAL, INC. 1916-A OLD MIDDLEFIELD WAY Mountain View, CA 94043 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-31 |
| Decision Date | 2005-02-24 |
| Summary: | summary |