Artivion, Inc
FDA Regulatory Profile
Artivion, Inc appears in FDA public data with 3 recalls, 1 510(k) clearance, 14 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2531-2024, Class II) was initiated on May 28, 2024. Its most recent 510(k) clearance was granted on October 2, 2025.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 1
- Inspections
- 14
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2531-2024 | Class II | CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft | May 28, 2024 |
| Z-2532-2024 | Class II | (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellular | May 28, 2024 |
| Z-1545-2024 | Class II | CryoValve SG Cryopreserved Pulmonary Human Heart Valve | March 6, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) | October 2, 2025 |