The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Guidant Vasoview Endoscopic Vessel Harvesting System.
| Device ID | K030512 |
| 510k Number | K030512 |
| Device Name: | GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Contact | Nancy Lince |
| Correspondent | Nancy Lince GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-19 |
| Decision Date | 2003-05-14 |
| Summary: | summary |