# DEN170004: Ellipsys Vascular Access System

- Pathway: De Novo (Direct)
- Applicant: Avenu Medical, Inc.
- Decided: Jun 22, 2018 after 528 days
- Product code: PQK (Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access)
- Device class: 2
- Regulation: 21 CFR 870.1252
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K181725: Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) (2018), 2 descendants of its own
- K183615: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle (2019), 1 descendant of its own
- K191114: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle (2019), 0 descendants of its own

## Indications for use
The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

Source page: https://510kreport.com/device/DEN170004
Methodology: https://510kreport.com/methodology