Medical Device Manufacturer · US , Mountain View , CA

Xlumena, Inc. - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2013

Recent clearances: AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)

View 2 510(k) Devices ↓

2

Total

1

Cleared

1

Denied

FDA 510(k) Regulatory Record - Xlumena, Inc. Gastroenterology & Urology ✕

2 devices

1-2 of 2

Cleared Apr 23, 2014

AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND...

Gastroenterology & Urology · 49d

Not Cleared Dec 18, 2013

AXIOS STENT AND DELIVERY SYSTEM

DEN130007 · PCU

Gastroenterology & Urology · 302d