EchoTip Insight Portosystemic Pressure Gradient Measuring System

Endoscopic Transhepatic Venous Access Needle

Cook Ireland Ltd.

The following data is part of a De Novo classification by Cook Ireland Ltd. with the FDA for Echotip Insight Portosystemic Pressure Gradient Measuring System.

Pre-market Notification Details

DeNovo IDDEN180062
Device Name:EchoTip Insight Portosystemic Pressure Gradient Measuring System
ClassificationEndoscopic Transhepatic Venous Access Needle
Applicant Cook Ireland Ltd. o'halloran Road, National Technology Park Limerick,  IE
ContactJane Kennedy
Product CodeQIJ  
CFR Regulation Number876.1050 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGastroenterology/Urology
Classification AdvisoryGastroenterology/Urology
TypeDirect
Date Received2018-11-19
Decision Date2019-11-20
Reclassification Order:Reclassification Order

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