Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM

K-Number: K040027 · 2004-03-30

Decision Date2004-03-30
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2004-03-30 under 510(k) number K040027. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM?

BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-30. The listed applicant is Boston Scientific. The 510(k) number is K040027.

When did BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM receive FDA 510(k) clearance?

BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM received FDA 510(k) clearance on 2004-03-30, under 510(k) number K040027.

Who is the listed applicant for BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM?

The FDA 510(k) record lists Boston Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM?

The FDA product code for BOSTON SCIENTIFIC EXPRESS BILIARY SD 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 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.

View all 50 devices →

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.

↑