The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Guidant Vasoview 6 Harvesting Cannula, Model Vh-2000; Guidant Vasoview 6 Accessory Pack, Model Vh-2004.
| Device ID | K041981 |
| 510k Number | K041981 |
| Device Name: | GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 |
| 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 | 2004-07-23 |
| Decision Date | 2004-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607567700437 | K041981 | 000 |
| 00607567700370 | K041981 | 000 |
| 00607567700369 | K041981 | 000 |