510(k) K092021 ยท OHA Heart Valve, More Than Minimally Manipulated Allograft
CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)
| Applicant | Cryolife, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, May 25, 2010 |
| Received | Jul 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092021
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2024 | Artivion, Inc CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology. Open, Classified |
OHA | None listed |
| Apr 16, 2024 | Artivion, Inc CryoValve SG Cryopreserved Pulmonary Human Heart Valve Open, Classified |
OHA | None listed |
| Nov 10, 2020 | CryoLife, Inc. 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 Terminated |
OHA | None listed |
| May 14, 2018 | CryoLife, Inc. Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO Terminated |
OHA | None listed |
| Mar 4, 2011 | CryoLife, Inc. Pulmonary Valve & Conduit SG
Used in heart surgery Terminated |
DXZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.