The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Virtuosaph Plus Endoscopic Vessel Harvesting System.
| Device ID | K140008 |
| 510k Number | K140008 |
| Device Name: | VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Terumo Cardiovascular Systems Corporation 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Garry Courtney |
| Correspondent | Garry Courtney Terumo Cardiovascular Systems Corporation 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-02 |
| Decision Date | 2014-10-31 |
| Summary: | summary |