Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant

SGY · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5881

Classification

FDA Product Code: SGY
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5881
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: Y
Implant: N
Third-party review: N

Definition

A hypothermic machine perfusion system and accessories for orthotopic liver transplant is a device that performs oxygenated perfusion of liver grafts at sub-physiological temperatures until it is transplanted into a recipient patient. This generic type of device may also include perfusion sets, oxygenators, and other components of the perfusion circuit.

Market data

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

Source

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