Cleared Traditional

WavelinQ Plus EndoAVF System

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

About This 510(k) Submission

K192239 is an FDA 510(k) clearance for the WavelinQ Plus EndoAVF System, a Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access (Class II — Special Controls, product code PQK), submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on October 17, 2019, 59 days after receiving the submission on August 19, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1252.

Submission Details

510(k) Number K192239 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code PQK — Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Device Class Class II — 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.

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