The following data is part of a premarket notification filed by Vivant Medical, Inc. with the FDA for Vivatip Microwave Ablation Probe.
| Device ID | K032702 |
| 510k Number | K032702 |
| Device Name: | VIVATIP MICROWAVE ABLATION PROBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VIVANT MEDICAL, INC. 1916-A OLD MIDDLEFIELD WAY Mountain View, CA 94043 |
| Contact | Steven Kim |
| Correspondent | Steven Kim 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 | 2003-09-02 |
| Decision Date | 2003-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884524000364 | K032702 | 000 |
| 10884521038738 | K032702 | 000 |
| 10884524001715 | K032702 | 000 |
| 10884524002286 | K032702 | 000 |
| 10884524002521 | K032702 | 000 |
| 10884524000671 | K032702 | 000 |
| 10884524000336 | K032702 | 000 |