Cleared Special

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

K183615 · Avenu Medical, Inc. · Cardiovascular

Jan 2019

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K183615 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), Crossing Needle, 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 January 25, 2019, 30 days after receiving the submission on December 26, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1252.

Submission Details

510(k) Number	K183615 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2018
Decision Date	January 25, 2019
Days to Decision	30 days
Submission Type	Special
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.