The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model Vh-3000.
| Device ID | K052274 |
| 510k Number | K052274 |
| Device Name: | GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GUIDANT CORPORATION 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Contact | M. Laurie Wong |
| Correspondent | M. Laurie Wong GUIDANT CORPORATION 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-22 |
| Decision Date | 2005-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607567700413 | K052274 | 000 |
| 00607567700345 | K052274 | 000 |