OKR

Ventricular Bypass (Assist) Device

Product code: OKR
Device name: Ventricular Bypass (Assist) Device
Device class: Class 3
21 CFR: 21 CFR 870.3545
Medical specialty: Cardiovascular
Marketing pathway: PMA

FDA classification definition

A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for <6 hours. The device is either totally or partially implanted in the body.

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

Official FDA classification page: OKR

Classification and pathway per current FDA publications. Data from openFDA (CC0).