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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 K183615
Device Name Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
Applicant
Avenu Medical, Inc.
27123 Calle Arroyo, Suite 2101
San Juan Capistrano,  CA  92675
Applicant Contact Dave Campbell
Correspondent
Avenu Medical, Inc.
27123 Calle Arroyo, Suite 2101
San Juan Capistrano,  CA  92675
Correspondent Contact Dave Campbell
Regulation Number870.1252
Classification Product Code
PQK  
Date Received12/26/2018
Decision Date 01/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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