The following data is part of a premarket notification filed by Bostonscientific with the FDA for Boston Scientific Express Biliary Sd Premounted Stent System.
| Device ID | K040027 |
| 510k Number | K040027 |
| Device Name: | BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | BOSTONSCIENTIFIC ONE SCIMED PLACE Maple Grove, MN 55311 |
| Contact | Candice R Burns |
| Correspondent | Candice R Burns BOSTONSCIENTIFIC ONE SCIMED PLACE Maple Grove, MN 55311 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-08 |
| Decision Date | 2004-03-30 |
| Summary: | summary |