The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Virtuosaph Plus Endoscopic Vessel Harvesting System.
| Device ID | K092789 |
| 510k Number | K092789 |
| Device Name: | VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Christina Thomas |
| Correspondent | Christina Thomas TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-10 |
| Decision Date | 2010-05-12 |
| Summary: | summary |