The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Niroyal Biliary Premounted Stent System.
| Device ID | K012216 |
| 510k Number | K012216 |
| Device Name: | NIROYAL BILIARY PREMOUNTED STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Candice Burns |
| Correspondent | Candice Burns BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-08-17 |
| Summary: | summary |