The following data is part of a premarket notification filed by Maquet Cardiovascular, Llc with the FDA for Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model Vh-2500.
| Device ID | K091733 |
| 510k Number | K091733 |
| Device Name: | VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MAQUET CARDIOVASCULAR, LLC 170 BAYTECH DRIVE San Jose, CA 95134 |
| Contact | Artie Kaushik |
| Correspondent | Artie Kaushik MAQUET CARDIOVASCULAR, LLC 170 BAYTECH DRIVE San Jose, CA 95134 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-11 |
| Decision Date | 2009-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607567700239 | K091733 | 000 |