OHA — Heart Valve, More Than Minimally Manipulated Allograft Class U
FDA product code OHA covers "Heart Valve, More Than Minimally Manipulated Allograft", a Class U medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OHA
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- Yes
Definition
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 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252059 | artivion | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit ( | October 2, 2025 |
| K092021 | cryolife | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) | May 25, 2010 |
| K083106 | cryolife | CRYOVALVE SG PULMONARY VALVE AND CONDUIT | February 6, 2009 |
| K033484 | cryolife | HUMAN HEART VALVE, CRYOVALVE SG | February 7, 2008 |