CRYOVALVE SG PULMONARY VALVE AND CONDUIT— 510(k) K083106

Substantially Equivalent

Cryolife, Inc.

FDA 510(k) clearance K083106 for CRYOVALVE SG PULMONARY VALVE AND CONDUIT, Substantially Equivalent on 2009-02-06. Applicant: Cryolife, Inc..

Clearance details

Applicant: Cryolife, Inc.
Product code: Code OHA
Advisory panel: Unknown
Date received: 2008-10-20
Decision date: 2009-02-06
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.