# K191114: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle

- Pathway: 510(k) (Traditional)
- Applicant: Avenu Medical
- Decided: Aug 9, 2019 after 105 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
Longest line of descent: 3 generations back to DEN170004 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183615: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle, Avenu Medical, Inc. (2019) Summary page 4.

## 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/K191114
Methodology: https://510kreport.com/methodology