510(k) K011676 ยท NEY System, Ablation, Microwave And Accessories
VIVAWAVE MICROWAVE SYSTEM
| Applicant | Vivant Medical, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Jun 18, 2002 |
| Received | May 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011676
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2011 | Covidien, PLC Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301.
Intended for the coagulation of soft tissue. Not intended for use in card Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.