FDA.reportPublic FDA data

Ellipsys Power Controller

Primary DI
B357AMI1000
Brand
Ellipsys Power Controller
Company
AVENU MEDICAL, INC.
Model
AMI1000
Published
2018-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
DEN170004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170004000Ellipsys Vascular Access SystemAvenu Medical, Inc.2018-06-22PQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B357AMI1000PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-276-2483dcampbell@avenumedical.com

Regulatory Flags#

DUNS number
053562774
Device count
1
Serial number
true
Manufacturing 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
00763000496982Ellipsys Vascular Access SystemAMI6005AMI6005 CE2021-02-08
00763000478193Ellipsys Power ControllerAMI10012021-01-27
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
00763000496982Ellipsys 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
B357AMI6050Ellipsys Vascular Access SystemAVENU MEDICAL, INC.PQK2018-09-18
00868260000211WavelinQTVA MEDICAL, INC.PQK2018-08-27