The following data is part of a premarket notification filed by Guidant Corporation, Cardiac Surgery with the FDA for Vasoview 6 Harvesting Cannula, Models Vh-2000, Vh-2001 & Vh-2002.
| Device ID | K022718 |
| 510k Number | K022718 |
| Device Name: | VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GUIDANT CORPORATION, CARDIAC SURGERY 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Contact | Anne Schlagenhaft |
| Correspondent | Peter N Ruys N.V. KEMA P.O. BOX 9035 6800 ET ARNHEM Arnhem, NL |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-08-15 |
| Decision Date | 2002-08-28 |
| Summary: | summary |