QIJ — Endoscopic Transhepatic Venous Access Needle Class II

FDA Device Classification

Classification Details

Product Code
QIJ
Device Class
Class II
Regulation Number
876.1050
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN180062cook irelandEchoTip Insight Portosystemic Pressure Gradient Measuring SystemNovember 20, 2019