The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Virtuosaph (tm) Endoscopic Vein Harvesting Disposable System, Model Mcvs550.
| Device ID | K083194 |
| 510k Number | K083194 |
| Device Name: | VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Junko Kurosawa |
| Correspondent | Junko Kurosawa 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 | 2008-10-29 |
| Decision Date | 2009-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00699753508729 | K083194 | 000 |
| 00699753508187 | K083194 | 000 |
| 00699753508163 | K083194 | 000 |
| 00699753508156 | K083194 | 000 |
| 50699753471004 | K083194 | 000 |
| 50699753021087 | K083194 | 000 |
| 50699753021070 | K083194 | 000 |
| 50699753019022 | K083194 | 000 |
| 00699753018969 | K083194 | 000 |
| 50699753508199 | K083194 | 000 |
| 50699753508205 | K083194 | 000 |
| 50699753508717 | K083194 | 000 |
| 00699753508705 | K083194 | 000 |
| 00699753508392 | K083194 | 000 |
| 50699753508380 | K083194 | 000 |
| 50699753508373 | K083194 | 000 |
| 00699753508262 | K083194 | 000 |
| 00699753508255 | K083194 | 000 |
| 00699753508248 | K083194 | 000 |
| 50699753018940 | K083194 | 000 |