WavelinQ 4F EndoAVF System

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

C. R. Bard, Inc.

The following data is part of a premarket notification filed by C. R. Bard, Inc. with the FDA for Wavelinq 4f Endoavf System.

Pre-market Notification Details

Device IDK182796
510k NumberK182796
Device Name:WavelinQ 4F EndoAVF System
ClassificationPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Applicant C. R. Bard, Inc. 1625 West 3rd Street Tempe,  AZ  85281
ContactKulveen Dhatt
CorrespondentKulveen Dhatt
C. R. Bard, Inc. 1625 West 3rd Street Tempe,  AZ  85281
Product CodePQK  
CFR Regulation Number870.1252 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-01
Decision Date2019-02-06
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.