FDA.reportPublic FDA data

Ellipsys Medical, Inc.

Matched from indexed company URL: Ellipsys, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Ellipsys Medical, Inc.5N2026-01-01990 Calle Negocio San Clemente CA US 92673

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00199874301785Ellipsys Medical - 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 and the Ellipsys Power Controller. The Catheter is a single-use, sterile disposable. The Power Controller is a reusable, non-sterile portable electronic console that is packaged and provided separately.657-660-1833customersupport@ellipsysmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3503681751625647K191114Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), NeedlePQK2019-08-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PQK12019-08-09

GUDID#

Ellipsys Medical - 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 and the Ellipsys Power Controller. The Catheter is a single-use, sterile disposable. The Power Controller is a reusable, non-sterile portable electronic console that is packaged and provided separately.

Ellipsys, Inc.

2026-06-03