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510(k) DEN180062

EchoTip Insight Portosystemic Pressure Gradient Measuring System by Cook Ireland, Ltd. — Product Code QIJ

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 20, 2019
Date Received
November 19, 2018
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Transhepatic Venous Access Needle
Device Class
Class II
Regulation Number
876.1050
Review Panel
GU
Submission Type

An endoscopic transhepatic venous access needle is inserted through the liver into the patient’s portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter.

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