QIKClass III

Organ Care System (Ocs) Heart System

Unknown

QIK is the FDA product code for Organ Care System (Ocs) Heart System, a class III device type. FDA's definition for this code reads: "A portable ex vivo organ perfusion system used to preserve a donor heart for transplantation into a potential recipient". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QIK
Device name: Organ Care System (Ocs) Heart System
FDA definition: A portable ex vivo organ perfusion system used to preserve a donor heart for transplantation into a potential recipient.
Device class: Class III
Review panel: Unknown
Submission type: PMA
Implant: No
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

Recent clearances

Product code QIK

FDA records hold no clearances under product code QIK.

Recent recalls

Product code QIK

FDA records show no recalls under product code QIK.

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)