OHA · Heart Valve, More Than Minimally Manipulated Allograft
· Class U
Overview
| Product Code | OHA |
|---|---|
| Device Name | Heart Valve, More Than Minimally Manipulated Allograft |
| Device Class | Class U |
| Review Panel | |
| Implant | Yes |
Identification
For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves. They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed. Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) | Artivion, Inc. | Oct 2, 2025 | SESE |
| K092021 | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) | Cryolife, Inc. | May 25, 2010 | SESE |
| K083106 | CRYOVALVE SG PULMONARY VALVE AND CONDUIT | Cryolife, Inc. | Feb 6, 2009 | SESE |
| K033484 | HUMAN HEART VALVE, CRYOVALVE SG | Cryolife, Inc. | Feb 7, 2008 | SESE |
Top Applicants
- Cryolife, Inc. — 3 clearances
- Artivion, Inc. — 1 clearance
