The following data is part of a premarket notification filed by Cryolife, Inc. with the FDA for Human Heart Valve, Cryovalve Sg.
| Device ID | K033484 |
| 510k Number | K033484 |
| Device Name: | HUMAN HEART VALVE, CRYOVALVE SG |
| Classification | Heart Valve, More Than Minimally Manipulated Allograft |
| Applicant | CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. Kennesaw, GA 30144 |
| Contact | David M Fronk |
| Correspondent | David M Fronk CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. Kennesaw, GA 30144 |
| Product Code | OHA |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-04 |
| Decision Date | 2008-02-07 |
| Summary: | summary |