QIJ

Endoscopic Transhepatic Venous Access Needle

Product code

QIJ

Device name

Endoscopic Transhepatic Venous Access Needle

Device class

Class 2

21 CFR

21 CFR 876.1050

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).