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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 K182796
Device Name WavelinQ 4F EndoAVF System
Applicant
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact Kulveen Dhatt
Correspondent
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact Kulveen Dhatt
Regulation Number870.1252
Classification Product Code
PQK  
Date Received10/01/2018
Decision Date 02/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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