CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)— 510(k) K092021
Substantially EquivalentCryolife, Inc.
FDA 510(k) clearance K092021 for CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT), Substantially Equivalent on 2010-05-25. Applicant: Cryolife, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Cryolife, Inc.
- Product code
- Code OHA
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kennesaw, GA, US
Recent devices under product code OHA
view allMore clearances from Cryolife, Inc.
view allAdverse events under product code OHA
product code OHA- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K092021
K-number listed on FDA's recall record- Z-2531-2024 — CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
- Z-1545-2024 — CryoValve SG Cryopreserved Pulmonary Human Heart Valve
- Z-0652-2021 — CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135¿C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.
- Z-2271-2018 — Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092021.
Data sourced from openFDA. This site is unofficial and independent of the FDA.