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) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K191114 · Avenu Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2019
Decision
105d
Days
Class 2
Risk

K191114 is an FDA 510(k) clearance for the Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys.... Classified as Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access (product code PQK), Class II - Special Controls.

Submitted by Avenu Medical (San Juan Capistrano, US). The FDA issued a Cleared decision on August 9, 2019 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1252 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Avenu Medical devices

Submission Details

510(k) Number K191114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02363972 Completed Interventional Industry-sponsored

Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

Ellipsys Vascular Access Catheter System Clinical Trial

103
Patients (actual)
5
Sites
Treatment
Purpose
Open label
Masking
Condition studied End Stage Renal Disease; AV Fistula; Fistula; End Stage Kidney Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Jeffrey Hull, MD
Sponsor Medtronic Endovascular (industry)
Started 2015-02-10 → Primary completion 2016-06-01
Primary outcome
Maturation Success Rate at 90 Days
Secondary outcome
Percent of Participants With Access Systems That Successfully Created an AVF
View full study on ClinicalTrials.gov

Regulatory Peers - PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Devices cleared under the same product code (PQK) and FDA review panel - the closest regulatory comparables to K191114.
WavelinQ Plus EndoAVF System
K192239 · C.R. Bard, Inc. · Oct 2019
WavelinQ 4F EndoAVF System
K182796 · C.R. Bard, Inc. · Feb 2019
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. · Jan 2019
Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
K181725 · Avenu Medical, Inc. · Oct 2018
everlinQ endoAVF System
DEN160006 · Tva Medical, Inc. · Jun 2018
Ellipsys Vascular Access System
DEN170004 · Avenu Medical, Inc. · Jun 2018