Cleared Traditional

WavelinQ Plus EndoAVF System (K192239) - FDA 510(k) Clearance

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

K192239 · C.R. Bard, Inc. · Cardiovascular device
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Oct 2019
Decision
59d
Days
Class 2
Risk

K192239 is an FDA 510(k) clearance for the WavelinQ Plus EndoAVF System. Classified as Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access (product code PQK), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on October 17, 2019 after a review of 59 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K192239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2019
Decision Date October 17, 2019
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
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.

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 K192239.
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
K191114 · Avenu Medical · Aug 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