K252059 is an FDA 510(k) clearance for the CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00). This device is classified as a Heart Valve, More Than Minimally Manipulated Allograft.
Submitted by Artivion, Inc. (Kennesaw, US). The FDA issued a Cleared decision on October 2, 2025, 93 days after receiving the submission on July 1, 2025.
This device falls under the Cardiovascular FDA review panel. 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..
| 510(k) Number | K252059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2025 |
| Decision Date | October 02, 2025 |
| Days to Decision | 93 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | OHA - Heart Valve, More Than Minimally Manipulated Allograft |
| Device Class | - |
| 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. |