De Novo DEN220026

Device
VasQ
Contact
orit yarden
De Novo number
DEN220026
Product code
QVQ
Regulation
870.4600
Classification name
extravascular support for an arteriovenous fistula for vascular access
Decision
granted (DENG)
Decision date
2023-09-26
Date received
2022-04-29
Classification advisory
Cardiovascular
Review advisory
Cardiovascular
Type
Direct

Current FDA Classification#

Product code
QVQ
Device name
Extravascular Support For An Arteriovenous Fistula For Vascular Access
Medical specialty
Cardiovascular
Device class
2
Regulation
870.4600
Implant
Y
Life sustain/support
N