CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)— 510(k) K252059

Substantially Equivalent

Artivion, Inc.

FDA 510(k) clearance K252059 for CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00), Substantially Equivalent on 2025-10-02. Applicant: Artivion, Inc..

Clearance details

Applicant: Artivion, Inc.
Product code: Code OHA
Advisory panel: Unknown
Date received: 2025-07-01
Decision date: 2025-10-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Kennesaw, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OHA

product code OHA

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.