Ellipsys Vascular Access System

Primary DI
00763000496982
Brand
Ellipsys Vascular Access System
Company
AVENU MEDICAL, INC.
Model
AMI6005
Catalog number
AMI6005 CE
Device 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.
Published
2021-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis AccessCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191114000Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), NeedleAvenu Medical2019-08-09PQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000496982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000496982007630004969827630004969820763000496982

GMDN Terms#

Term, Definition table
TermDefinition
Electrocautery system, line-poweredAn assembly of line-powered devices designed to regulate an electrical current used to heat the electrode tip or wire loop of a cutting instrument intended to burn or sear body tissues during surgery. It is typically used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions (e.g., removal of warts, removal of gastrointestinal polyps via an appropriate endoscope), or to occlude fallopian tubes during sterilization procedures. It typically consists of a generator, a handpiece, and electrodes. Unlike electrosurgical diathermy, electrocautery does not involve electrical current passing through the patient.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-949-276-2483customerservice@avenumedical.com

Regulatory Flags#

DUNS number
053562774
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000574710Ellipsys Power ControllerAMI10012021-12-10
00763000496975Ellipsys Vascular Access SystemAMI6005AMI6005 US2021-02-08
00763000478193Ellipsys Power ControllerAMI10012021-01-27
B357AMI1000Ellipsys Power ControllerAMI10002018-09-18
B357AMI1001Ellipsys Power ControllerAMI10012018-10-24
B357AMI6005Ellipsys Vascular Access SystemAMI60052018-10-24
B357AMI6050Ellipsys Vascular Access SystemAMI60502018-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000574710Ellipsys Power ControllerAVENU MEDICAL, INC.PQK2021-12-10
00763000496975Ellipsys Vascular Access SystemAVENU MEDICAL, INC.PQK2021-02-08
00763000478193Ellipsys Power ControllerAVENU MEDICAL, INC.PQK2021-01-27
00801741189104WavelinQCLEARSTREAM TECHNOLOGIES LIMITEDPQK2019-11-15
00801741182754WavelinQBard Peripheral Vascular, Inc.PQK2019-02-22
B357AMI1001Ellipsys Power ControllerAVENU MEDICAL, INC.PQK2018-10-24
B357AMI6005Ellipsys Vascular Access SystemAVENU MEDICAL, INC.PQK2018-10-24
B357AMI1000Ellipsys Power ControllerAVENU MEDICAL, INC.PQK2018-09-18
B357AMI6050Ellipsys Vascular Access SystemAVENU MEDICAL, INC.PQK2018-09-18
00868260000211WavelinQTVA MEDICAL, INC.PQK2018-08-27