# QIK · Organ Care System (Ocs) Heart System

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/CV-misc/QIK

## Overview

- **Product Code:** QIK
- **Device Name:** Organ Care System (Ocs) Heart System
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Life-sustaining:** yes

## Identification

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

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P180051](https://fda.innolitics.com/submissions/CV/CV-misc/QIK/P180051.md) | Organ Care System (OCS) Heart System | TransMedics, Inc. | Sep 3, 2021 | APPR |

## Top Applicants

- TransMedics, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/CV-misc/QIK](https://fda.innolitics.com/submissions/CV/CV-misc/QIK)

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