510(k) K092021
K092021 is an FDA 510(k) premarket notification submitted by Cryolife, Inc. for the device "CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)". The FDA issued a decision of Substantially Equivalent on May 25, 2010. The device falls under product code OHA (Heart Valve, More Than Minimally Manipulated Allograft), a Class U device. Cryolife, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2010
- Date Received
- July 6, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Heart Valve, More Than Minimally Manipulated Allograft
- Device Class
- Class U
- Regulation Number
- Review Panel
- CV
- Submission Type
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.