The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Otw Megalink Sds Billiary Stent System, Models 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1.
| Device ID | K001222 |
| 510k Number | K001222 |
| Device Name: | OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1 |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Contact | Margaret Anderson |
| Correspondent | Margaret Anderson 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 | 2000-04-17 |
| Decision Date | 2000-05-17 |