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. The Ellipsys Power Controller is a reusable, non-sterile portable electronic console that is packaged and provided separately. FDA UDI
- Model / Reference
- AMI6005 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. The Ellipsys Power Controller is a reusable, non-sterile portable electronic console that is packaged and provided separately. FDA UDI
Identifiers
- Catalog Number
- AMI6005 CE FDA UDI
- Primary DI / UDI-DI
- 00763000496982 FDA UDI
- 510(k) Number
- K191114 FDA UDI
- FDA Product Code
- PQK FDA UDI
- GMDN Term
- Electrocautery system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1252 FDA UDI
- 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
Dimensions & Sizes
- Size
- Catheter Gauge — 6 French FDA UDI
Category: Electrocautery system, line-powered
Ellipsys Vascular Access System by Avenu Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocautery system, line-powered.
- Geiger TCU 100 Handpiece — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
- Ellipsys Power Controller — Avenu Medical · Class II
- Ellipsys Vascular Access System — Avenu Medical · Class II
- Ellipsys Power Controller — Avenu Medical · Class II
- Ellipsys Vascular Access System — Avenu Medical · Class II
- Ellipsys Power Controller — Avenu Medical · Class II
- Ellipsys Power Controller — Avenu Medical · Class II
Cleared under the same submission
K191114 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Avenu Medical
Sources (1)
- FDA UDI d91824da-543e-44ed-8460-a578d5f4169a 38 fields · synced Jun 1, 2026