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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
510(k) Number K192239
Device Name WavelinQ Plus EndoAVF System
Applicant
C.R. Bard, Inc.
1625 West 3rd Street
Tempe,  AZ  85281
Applicant Contact Kulveen Dhatt
Correspondent
C.R. Bard, Inc.
1625 West 3rd Street
Tempe,  AZ  85281
Correspondent Contact Kulveen Dhatt
Regulation Number870.1252
Classification Product Code
PQK  
Date Received08/19/2019
Decision Date 10/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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