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 | K160206 |
| 510k Number | K160206 |
| Device Name: | VirtuoSaph Plus Endoscopic Vessel Harvesting System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 |
| Contact | Tierra A Brown |
| Correspondent | Tierra A Brown Terumo Cardiovascular Systems Corporation 125 Blue Ball Road 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 | 2016-01-28 |
| Decision Date | 2016-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753450764 | K160206 | 000 |
| 00699753023222 | K160206 | 000 |
| 50699753022961 | K160206 | 000 |
| 00699753018952 | K160206 | 000 |