510(k) K140008 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
| Applicant | Terumo Cardiovascular Systems Corporation, Elkton MD, US |
| Decision | Substantially Equivalent, Oct 31, 2014 |
| Received | Jan 2, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2018 | Terumo Cardiovascular Systems Corporation VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX
Product Usage:
The VittuoSaph Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasiv Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.