510(k) K083106
- Device
- CRYOVALVE SG PULMONARY VALVE AND CONDUIT
- Applicant
- CRYOLIFE, INC.
- 510(k) number
- K083106
- Product code
- OHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-02-06
- Date received
- 2008-10-20
- Regulation
- 510(k) Premarket Notification
- Classification name
- Heart Valve, More Than Minimally Manipulated Allograft
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Cardiovascular
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN D FERROS
- Address
- 1655 Roberts Blvd. NW Kennesaw GA US 30144 30144
FDA Registration Numbers#
- 1526611
- 1063481
Source Documents#
Other 510(k) Records For Product Code OHA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) | Artivion, Inc. | 2025-10-02 |
| K092021 | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) | Cryolife, Inc. | 2010-05-25 |
| K033484 | HUMAN HEART VALVE, CRYOVALVE SG | Cryolife, Inc. | 2008-02-07 |
Legacy Summary#
summary
FDA Review#
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