Cleared Traditional

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle

K191114 · Avenu Medical · Cardiovascular

Aug 2019

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K191114 is an FDA 510(k) clearance for the Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle, a Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access (Class II — Special Controls, product code PQK), submitted by Avenu Medical (San Juan Capistrano, US). The FDA issued a Cleared decision on August 9, 2019, 105 days after receiving the submission on April 26, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1252.

Submission Details

510(k) Number	K191114 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2019
Decision Date	August 09, 2019
Days to Decision	105 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.