Express SD Biliary Monorail Premounted Stent System
K-Number: K162404 · 2016-10-12
Device Summary
Frequently Asked Questions
What is the Express SD Biliary Monorail Premounted Stent System?
Express SD Biliary Monorail Premounted Stent System is a medical device that received FDA 510(k) clearance on 2016-10-12. The listed applicant is Boston Scientific Corporation. The 510(k) number is K162404.
When did Express SD Biliary Monorail Premounted Stent System receive FDA 510(k) clearance?
Express SD Biliary Monorail Premounted Stent System received FDA 510(k) clearance on 2016-10-12, under 510(k) number K162404.
Who is the listed applicant for Express SD Biliary Monorail Premounted Stent System?
The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Express SD Biliary Monorail Premounted Stent System?
The FDA product code for Express SD Biliary Monorail Premounted Stent System is FGE.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Boston Scientific Corporation as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: FGE)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.