Product code OHA ยท Class U
Heart Valve, More Than Minimally Manipulated Allograft
0510(k)s in 12 months (4 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in OHA
| Company | 510(k)s | Recalls |
|---|---|---|
| Cryolife, Inc. | 3 | 2 |
| Artivion, Inc. | 1 | 2 |
| 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 | K092021 |
| Apr 16, 2024 | Artivion, Inc CryoValve SG Cryopreserved Pulmonary Human Heart Valve Open, Classified |
OHA | K092021 |
| 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 | K092021 |
| May 14, 2018 | CryoLife, Inc. Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO Terminated |
OHA | K092021 |
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