De Novo DEN050006

Device
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
Contact
carol vierling
De Novo number
DEN050006
Product code
NQH
Regulation
870.2855
Classification name
sensor, pressure, aneurysm, implantable
Decision
granted (DENG)
Decision date
2005-10-28
Date received
2005-08-09
Classification advisory
Cardiovascular
Review advisory
Cardiovascular
Type
Post-NSE

Current FDA Classification#

Product code
NQH
Device name
Sensor, Pressure, Aneurysm, Implantable
Medical specialty
Cardiovascular
Device class
2
Regulation
870.2855
Implant
Y
Life sustain/support
N