Ellipsys Vascular Access System

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Avenu Medical, Inc

The following data is part of a De Novo classification by Avenu Medical, Inc with the FDA for Ellipsys Vascular Access System.

Pre-market Notification Details

DeNovo IDDEN170004
Device Name:Ellipsys Vascular Access System
ClassificationPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Applicant Avenu Medical, Inc 27123 Calle Arroyo, Suite 2101 San Juan Capistrano,  CA  92675
ContactRebecca K. Pine
Product CodePQK  
CFR Regulation Number870.1252 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardCardiovascular
Classification AdvisoryCardiovascular
TypeDirect
Date Received2017-01-10
Decision Date2018-06-22
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B357AMI6050 DEN170004 000
B357AMI1000 DEN170004 000
B357AMI6050 DEN170004 000
B357AMI1000 DEN170004 000

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