Endoscopic Transhepatic Venous Access Needle

QIJ · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1050

Classification

FDA Product Code: QIJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.1050
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

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

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown