Product code QIJ

Device name

Endoscopic Transhepatic Venous Access Needle

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.1050

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset