510(k) K252059
K252059 is an FDA 510(k) premarket notification submitted by Artivion, Inc. for the device "CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)". The FDA issued a decision of Substantially Equivalent on October 2, 2025. The device falls under product code OHA (Heart Valve, More Than Minimally Manipulated Allograft), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2025
- Date Received
- July 1, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Heart Valve, More Than Minimally Manipulated Allograft
- Device Class
- Class U
- Regulation Number
- Review Panel
- CV
- Submission Type
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.