Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Avenu Medical, Inc.

The following data is part of a premarket notification filed by Avenu Medical, Inc. with the FDA for Ellipsys Vascular Access System (ellipsys System), (power Controller Model No. Ami-1001 & Catheter & Needle Model No. Ami-6005).

Pre-market Notification Details

Device IDK181725
510k NumberK181725
Device Name:Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
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
CorrespondentRebecca K. Pine
Avenu Medical, Inc. 27123 Calle Arroyo, Suite 2101 San Juan Capistrano,  CA  92675
Product CodePQK  
CFR Regulation Number870.1252 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-29
Decision Date2018-10-05
Summary:summary

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