QIK

Organ Care System (Ocs) Heart System

Product code
QIK
Device name
Organ Care System (Ocs) Heart System
Device class
Class 3
Medical specialty
Unknown
Marketing pathway
PMA
Flag
Life-sustaining / life-supporting

FDA classification definition

A portable ex vivo organ perfusion system used to preserve a donor heart for transplantation into a potential recipient.

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

Official FDA classification page: QIK
Classification and pathway per current FDA publications. Data from openFDA (CC0).