The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Guidant Megalink Biliary Stent, Model Fg1002949-58.
| Device ID | K991032 |
| 510k Number | K991032 |
| Device Name: | GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58 |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Contact | Kobby Dankwah |
| Correspondent | Kobby Dankwah GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-29 |
| Decision Date | 1999-04-30 |
| Summary: | summary |