CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)— 510(k) K092021

Substantially Equivalent

Cryolife, Inc.

FDA 510(k) clearance K092021 for CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT), Substantially Equivalent on 2010-05-25. Applicant: Cryolife, Inc..

Clearance details

Applicant: Cryolife, Inc.
Product code: Code OHA
Advisory panel: Unknown
Date received: 2009-07-06
Decision date: 2010-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennesaw, GA, US

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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.