avenumedical.c
avenumedical.comEllipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
Avenu Medical
AVENU MEDICAL (FORMERLY CAYMUS MEDICAL)
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014251914 | 3014251914 | AVENU MEDICAL (FORMERLY CAYMUS MEDICAL) | 1 | Y | 2020-04-25 | 27123 CALLE ARROYO # 2101 San Juan Capistrano CA US 92675 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00763000496975 | Ellipsys Vascular Access System - 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. | +1-949-276-2483 | customerservice@avenumedical.com |
| 00763000496982 | Ellipsys Vascular Access System - 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. | +1-949-276-2483 | customerservice@avenumedical.com |
| B357AMI1000 | Ellipsys Power Controller - AMI1000 | 949-276-2483 | dcampbell@avenumedical.com |
| B357AMI1001 | Ellipsys Power Controller - The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter. | +1(949)-276-2483 | customerservice@avenumedical.c |
| B357AMI1001 | Ellipsys Power Controller - The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter. | +1(949)-276-2483 | customerservice@avenumedical.com |
| B357AMI6005 | Ellipsys Vascular Access System - 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. | +1(949)-276-2483 | customerservice@avenumedical.c |
| B357AMI6005 | Ellipsys Vascular Access System - 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. | +1(949)-276-2483 | customerservice@avenumedical.com |
| B357AMI6050 | Ellipsys Vascular Access System - 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. | 949-276-2483 | dcampbell@avenumedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 220982 | 1358199726 | K191114 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle | PQK | 2019-08-09 |
| 220982 | 1788686506 | K183615 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle | PQK | 2019-01-25 |
| 220982 | 1751495935 | K181725 | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) | PQK | 2018-10-05 |
| 220982 | 1480309183 | DEN170004 | Ellipsys Vascular Access System | PQK | 2018-06-22 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PQK | 4 | 2019-08-09 |
PMN#
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.
Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
Avenu Medical, Inc.
GUDID#
Ellipsys Vascular Access System - 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.
2018-09-18
Ellipsys Vascular Access System - 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.
2018-10-24
Ellipsys Power Controller - The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter.
2018-10-24
Ellipsys Power Controller - AMI1000
2018-09-18
Ellipsys Power Controller - The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter.
2021-01-27
Ellipsys Vascular Access System - 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.
2021-02-08
Ellipsys Vascular Access System - 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.
2021-02-08
Ellipsys Power Controller - The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter.
2021-12-10