Not Cleared Direct

DEN170004 - Ellipsys Vascular Access System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN170004 · Avenu Medical, Inc. · Cardiovascular device
Jun 2018
Decision
528d
Days
Class 2
Risk

DEN170004 is an FDA 510(k) submission (not cleared) for the Ellipsys Vascular Access System. Classified as Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access (product code PQK), Class II - Special Controls.

Submitted by Avenu Medical, Inc. (San Juan Capistrano, US). The FDA issued a Not Cleared (DENG) decision on June 22, 2018 after a review of 528 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 528 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

Submission Details

510(k) Number DEN170004 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 10, 2017
Decision Date June 22, 2018
Days to Decision 528 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Regulatory Context
Review time vs. panel average
388d slower than avg
Panel avg: 140d · This submission: 528d
Pathway characteristics

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.