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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name endoscopic transhepatic venous access needle
De Novo Number DEN180062
Device Name EchoTip Insight Portosystemic Pressure Gradient Measuring System
Requester
cook ireland, ltd.
o' halloran rd., national technology park
limerick,  IE
Contact jane kennedy
Regulation Number876.1050
Classification Product Code
QIJ  
Date Received11/19/2018
Decision Date 11/20/2019
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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