Cleared Special

K183615 - Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle (FDA 510(k) Clearance)

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

K183615 · Avenu Medical, Inc. · Cardiovascular device
Jan 2019
Decision
30d
Days
Class 2
Risk

K183615 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, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on January 25, 2019 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1252 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K183615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.