Cleared Traditional

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

K181725 · Avenu Medical, Inc. · Cardiovascular

Oct 2018

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K181725 is an FDA 510(k) clearance for the Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005), a Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access (Class II — Special Controls, product code PQK), submitted by Avenu Medical, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on October 5, 2018, 98 days after receiving the submission on June 29, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1252.

Submission Details

510(k) Number	K181725 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2018
Decision Date	October 05, 2018
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	PQK — Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1252
Definition	Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access. This Device Is A Single Use Percutaneous Catheter System That Creates An Arteriovenous Fistula In The Arm Of Patients With Chronic Kidney Disease Who Need Hemodialysis.