Cleared Traditional

WavelinQ 4F EndoAVF System

K182796 · C.R. Bard, Inc. · Cardiovascular
Feb 2019
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K182796 is an FDA 510(k) clearance for the WavelinQ 4F 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 February 6, 2019, 128 days after receiving the submission on October 1, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1252.

Submission Details

510(k) Number K182796 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2018
Decision Date February 06, 2019
Days to Decision 128 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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