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

Name: FDA 510(k) clearance K252059
Creator: U.S. Food and Drug Administration
Published: 2025-10-02

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.. Device class: Unclassified.

Clearance details

Applicant: Artivion, Inc.
Product code: Code OHA
Device class: Unclassified
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 ↗

Recent devices under product code OHA

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K092021 — CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)2010-05-25
K083106 — CRYOVALVE SG PULMONARY VALVE AND CONDUIT2009-02-06
K033484 — HUMAN HEART VALVE, CRYOVALVE SG2008-02-07

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.