QIK · Organ Care System (Ocs) Heart System
· Class 3
Overview
| Product Code | QIK |
|---|---|
| Device Name | Organ Care System (Ocs) Heart System |
| Device Class | Class 3 |
| Review Panel | |
| 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 | Organ Care System (OCS) Heart System | TransMedics, Inc. | Sep 3, 2021 | APPR |
Top Applicants
- TransMedics, Inc. — 1 clearance
