AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)— 510(k) K140561

Substantially Equivalent

Xlumena, Inc.

FDA 510(k) clearance K140561 for AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT), Substantially Equivalent on 2014-04-23. Applicant: Xlumena, Inc..

Clearance details

Applicant: Xlumena, Inc.
Product code: Code PCU
Advisory panel: Gastroenterology, Urology
Date received: 2014-03-05
Decision date: 2014-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PCU

product code PCU

Death: 47
Injury: 804
Malfunction: 709
Total: 1,560

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.