The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Guidant Megalink Biliary Stent, Model #'s 1002949-18, 1002949-28, 1002949-38.
| Device ID | K983075 |
| 510k Number | K983075 |
| Device Name: | GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38 |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Contact | Sandra Sundell |
| Correspondent | Sandra Sundell GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-02 |
| Decision Date | 1999-03-03 |
| Summary: | summary |