WallFlex Biliary RX Fully Covered Stent System RMV— 510(k) DEN150040

Name: FDA 510(k) clearance DEN150040
Creator: U.S. Food and Drug Administration
Published: 2016-06-03

Unknown

Boston Scientific

FDA 510(k) clearance DEN150040 for WallFlex Biliary RX Fully Covered Stent System RMV, Unknown on 2016-06-03. Applicant: Boston Scientific. Device class: 2.

Clearance details

Applicant: Boston Scientific
Product code: Code PNB
Device class: Class 2
Regulation: 21 CFR 876.5011
Advisory panel: Gastroenterology, Urology
Date received: 2015-08-28
Decision date: 2016-06-03
Decision: Unknown
Clearance type: Direct
Location: Marlboro, MA, US

View on FDA.gov ↗

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Adverse events under product code PNB

product code PNB

Death: 4
Injury: 132
Total: 136

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.