The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Express Sd Biliary Monorail Premounted Stent System.
| Device ID | K162404 |
| 510k Number | K162404 |
| Device Name: | Express SD Biliary Monorail Premounted Stent System |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Ka Zoua Xiong |
| Correspondent | Ka Zoua Xiong BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-29 |
| Decision Date | 2016-10-12 |
| Summary: | summary |