The following data is part of a premarket notification filed by Boston Scientific with the FDA for Express Sd Biliary Monorail Premounted Stent System.
Device ID | K152607 |
510k Number | K152607 |
Device Name: | Express SD Biliary Monorail Premounted Stent System |
Classification | Stents, Drains And Dilators For The Biliary Ducts |
Applicant | BOSTON SCIENTIFIC ONE SCIMED PLACE Maple Grove, MN 55311 |
Contact | Anna Deraney |
Correspondent | Anna Deraney BOSTON SCIENTIFIC ONE SCIMED PLACE Maple Grove, MN 55311 |
Product Code | FGE |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-11 |
Decision Date | 2015-10-27 |
Summary: | summary |