Cryovalve SG Pulmonary Valve and Conduit
FDA 510(k) K083106 · Cryolife, Inc.
510(k) numberK083106
Submission
- Device name
- Cryovalve SG Pulmonary Valve and Conduit
- Applicant
- Cryolife, Inc.
Kennesaw, GA, US - Received
- October 20, 2008
- Decision date
- February 6, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OHA – Heart Valve, More Than Minimally Manipulated Allograft
- Device class
- Unclassified
- Implant
- Yes
For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves. They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed. Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions.
Other 510(k)s with product code OHA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)OHA · Special | Artivion, Inc. | 10/02/2025SE |
| K092021 | Cryovalve SG Pulmonary Human Heart Valve (and Conduit)OHA · Traditional | Cryolife, Inc. | 05/25/2010SE |
| K033484 | Human Heart Valve, Cryovalve SGOHA · Traditional | Cryolife, Inc. | 02/07/2008SE |
More from Cryolife, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K183635 | PhotoFix Decellularized Bovine PericardiumPSQ · Special | 02/14/2019SE |
| K172085 | PhotoFix Decellularized Bovine PericardiumPSQ · Traditional | 12/04/2017SE |
| K162506 | PhotoFix Decellularized Bovine PericardiumDXZ · Traditional | 03/09/2017SE |
| K132105 | Perclot TopicalQSY · Traditional | 04/03/2014SE |
| K110581 | Propatch Soft Tissue Repair MatrixFTM · Traditional | 01/10/2012SE |
| K101587 | Propatch Soft Tissue Repair MatrixFTM · Traditional | 09/16/2010SE |
| K101866 | Cryopatch SG Pulmonary Human Cardiac PatchDXZ · Special | 07/23/2010SE |
| K092021 | Cryovalve SG Pulmonary Human Heart Valve (and Conduit)OHA · Traditional | 05/25/2010SE |
| K091626 | Cryopatch SG Pulmonary Hemi-Artery; Trunk; BranchDXZ · Traditional | 08/07/2009SE |
| K033484 | Human Heart Valve, Cryovalve SGOHA · Traditional | 02/07/2008SE |
Questions and answers
When was Cryovalve SG Pulmonary Valve and Conduit cleared by the FDA?
Cryovalve SG Pulmonary Valve and Conduit (K083106) received a 510(k) decision of Substantially Equivalent on February 6, 2009, 109 days after the submission was received.
What is the product code of K083106?
The FDA product code is OHA – Heart Valve, More Than Minimally Manipulated Allograft, a Unclassified device.