Heart Valve, More Than Minimally Manipulated Allograft
The Heart Valve, More Than Minimally Manipulated Allograft is a processed human heart valve allograft used for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary heart valves, including use in the Ross procedure and repair of congenital and acquired valvular lesions. It is classified as FDA Unclassified (class U) with an unclassified reason indicating the device is pending classification, reviewed by the Cardiovascular panel, and requires a 510(k) or other premarket submission pathway to be determined. The product code is OHA; no regulation number is assigned. It is flagged as an implant device.
Research product code OHA in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OHA
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) | Oct 02, 2025 | Substantially Equivalent | Artivion, Inc. |
| K092021 | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) | May 25, 2010 | Substantially Equivalent | Cryolife, Inc. |
| K083106 | CRYOVALVE SG PULMONARY VALVE AND CONDUIT | Feb 06, 2009 | Substantially Equivalent | Cryolife, Inc. |
| K033484 | HUMAN HEART VALVE, CRYOVALVE SG | Feb 07, 2008 | Substantially Equivalent | Cryolife, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.