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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 K191114
Device Name Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
Applicant
Avenu Medical
27123 Calle Arroyo, Suite 2101
San Juan Capistrano,  CA  92675
Applicant Contact Dave Campbell
Correspondent
Avenu Medical
27123 Calle Arroyo, Suite 2101
San Juan Capistrano,  CA  92675
Correspondent Contact Dave Campbell
Regulation Number870.1252
Classification Product Code
PQK  
Date Received04/26/2019
Decision Date 08/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT02363972
Reviewed by Third Party No
Combination Product No
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