AXIOS STENT AND DELIVERY SYSTEM— 510(k) DEN130007

Unknown

Xlumena, Inc.

FDA 510(k) clearance DEN130007 for AXIOS STENT AND DELIVERY SYSTEM, Unknown on 2013-12-18. Applicant: Xlumena, Inc..

Clearance details

Applicant: Xlumena, Inc.
Product code: Code PCU
Advisory panel: Gastroenterology, Urology
Date received: 2013-02-19
Decision date: 2013-12-18
Decision: Unknown
Clearance type: Post-NSE
Location: Mountain View, CA, US

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.