Cleared Traditional

K181725 - Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181725 · Avenu Medical, Inc. · Cardiovascular device
Oct 2018
Decision
98d
Days
Class 2
Risk

K181725 is an FDA 510(k) clearance for the Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No.... 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 October 5, 2018 after a review of 98 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.

Submission Details

510(k) Number K181725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2018
Decision Date October 05, 2018
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 140d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.