FDA.reportPublic FDA data

De Novo DEN080015

Device
NUCLEUS-X PTV CATHETER
Contact
nichelle laflesh
De Novo number
DEN080015
Product code
OZT
Regulation
870.1255
Classification name
balloon aortic valvuloplasty
Decision
granted (DENG)
Decision date
2012-06-11
Date received
2008-12-24
Classification advisory
Cardiovascular
Review advisory
Cardiovascular
Type
Post-NSE

Current FDA Classification#

Product code
OZT
Device name
Balloon Aortic Valvuloplasty
Medical specialty
Cardiovascular
Device class
2
Regulation
870.1255
Implant
N
Life sustain/support
N