De Novo DEN170004
- Device
- Ellipsys Vascular Access System
- Contact
- rebecca k. pine
- De Novo number
- DEN170004
- 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
- 2017-01-10
- 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