The following data is part of a premarket notification filed by Guidant Corp. with the FDA for 7mm Extended Length Endoscope,dissection Tips, Models Vh-1111, Vh-1114.
| Device ID | K014250 |
| 510k Number | K014250 |
| Device Name: | 7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Contact | Anne Schlagenhaft |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-12-26 |
| Decision Date | 2002-01-10 |
| Summary: | summary |