Avenu Medical, Inc

FDA Filings

This page includes the latest FDA filings for Avenu Medical, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Avenu Medical
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle2019-08-09
Avenu Medical, Inc.
Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)2018-10-05

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate
Avenu Medical, Inc
Ellipsys Vascular Access System2018-06-22

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Ellipsys Vascular Access System
AVENU MEDICAL, INC.2019-01-29
Ellipsys Power Controller
AVENU MEDICAL, INC.2018-11-26
Ellipsys Vascular Access System
AVENU MEDICAL, INC.2018-10-19
Ellipsys Power Controller
AVENU MEDICAL, INC.2018-10-19

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