PCKHumanitarian device exemption

Pediatric Ventricular Assist Device

21 CFR 870.3545 / Cardiovascular

PCK is the FDA product code for Pediatric Ventricular Assist Device, regulated under 21 CFR 870.3545. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PCK
Device name: Pediatric Ventricular Assist Device
FDA 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.
Regulation: 21 CFR 870.3545
Device class: Humanitarian device exemption
Review panel: Cardiovascular
Submission type: FDA code 6
Implant: Yes
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Berlin Heart GmbH

Recent clearances

Product code PCK

FDA records hold no clearances under product code PCK.

Recent recalls

Product code PCK

FDA records show no recalls under product code PCK.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)