The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Rx Megalink Sds Biliary Stent System, Otw Megalink Sds Biliary Stent System.
| Device ID | K992319 |
| 510k Number | K992319 |
| Device Name: | RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
| Contact | Sandra Sundell |
| Correspondent | Sandra Sundell GUIDANT CORP. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-12 |
| Decision Date | 1999-10-08 |
| Summary: | summary |