← Back to catalogue

Ellipsys Vascular Access System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) DEN170004

by Avenu Medical, Inc.

Identity

Trade Name
Ellipsys Vascular Access System FDA UDI
Generic Name
Electrocautery system, line-powered FDA UDI
Device Name
The Ellipsys Vascular Access 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. The main components of the Ellipsys Vascular Access System are the Ellipsys Catheter, the Ellipsys Crossing Needle, and the Ellipsys Power Controller. The Crossing Needle and Catheter are single-use, sterile disposables that are packaged together, and referred to as the Ellipsys Vascular Access Kit. The Ellipsys Power Controller is a reusable, non-sterile portable electronic console that is packaged and provided separately. FDA UDI
Model / Reference
AMI6050 FDA UDI
Description
The Ellipsys Vascular Access 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. The main components of the Ellipsys Vascular Access System are the Ellipsys Catheter, the Ellipsys Crossing Needle, and the Ellipsys Power Controller. The Crossing Needle and Catheter are single-use, sterile disposables that are packaged together, and referred to as the Ellipsys Vascular Access Kit. The Ellipsys Power Controller is a reusable, non-sterile portable electronic console that is packaged and provided separately. FDA UDI

Identifiers

Primary DI / UDI-DI
B357AMI6050 FDA UDI
510(k) Number
DEN170004 FDA 510(k)FDA UDI
FDA Product Code
PQK FDA 510(k)FDA UDI
GMDN Term
Electrocautery system, line-powered FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 870.1252 FDA 510(k)
Regulation Number
870.1252 FDA 510(k)FDA UDI
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
DENG FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Ellipsys Vascular Access System by Avenu Medical, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Avenu Medical, Inc.

Sources (2)

  • FDA 510(k) DEN170004 24 fields · synced Jun 19, 2026
  • FDA UDI 80a183c1-2a8b-4223-a1ba-cc40c6706471 36 fields · synced May 27, 2026