FDA.reportPublic FDA data

De Novo DEN160006

Device
everlinQ endoAVF System
Contact
noah bartsch
De Novo number
DEN160006
Product code
PQK
Regulation
870.1252
Classification name
percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access
Decision
granted (DENG)
Decision date
2018-06-22
Date received
2016-02-03
Classification advisory
Cardiovascular
Review advisory
Cardiovascular
Type
Direct

Current FDA Classification#

Product code
PQK
Device name
Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Medical specialty
Cardiovascular
Device class
2
Regulation
870.1252
Implant
N
Life sustain/support
N