AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent) +1 more— 510(k) DEN230019

Name: FDA 510(k) clearance DEN230019
Creator: U.S. Food and Drug Administration
Published: 2023-08-18

Unknown

Boston Scientific Corporation

FDA 510(k) clearance DEN230019 for AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent) +1 more, Unknown on 2023-08-18. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Device name as filed: AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent)
Applicant: Boston Scientific Corporation
Product code: Code QXH
Device class: Class 2
Regulation: 21 CFR 876.5016
Advisory panel: Gastroenterology, Urology
Date received: 2023-03-27
Decision date: 2023-08-18
Decision: Unknown
Clearance type: Direct
Location: Marlboro, MA, US

View on FDA.gov ↗

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Adverse events under product code QXH

product code QXH

Death: 4
Total: 4

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.