FDA.reportPublic FDA data

De Novo DEN130007

Device
AXIOS STENT AND DELIVERY SYSTEM
Contact
jane beggs
De Novo number
DEN130007
Product code
PCU
Regulation
876.5015
Classification name
pancreatic stent, covered, metallic, removable
Decision
granted (DENG)
Decision date
2013-12-18
Date received
2013-02-19
Classification advisory
Gastroenterology/Urology
Review advisory
Gastroenterology/Urology
Type
Post-NSE

Current FDA Classification#

Product code
PCU
Device name
Pancreatic Stent, Covered, Metallic, Removable
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation
876.5015
Implant
Y
Life sustain/support
N