PCK

Pediatric Ventricular Assist Device

Product code: PCK
Device name: Pediatric Ventricular Assist Device
Device class: Class F
21 CFR: 21 CFR 870.3545
Medical specialty: Cardiovascular
Marketing pathway: HDE - Humanitarian Device Exemption
Flag: Implant
Flag: Life-sustaining / life-supporting

FDA classification definition

A ventricular assist device (VAD) assists the left or right ventricle in maintaining circulatory blood flow. 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: PCK

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