The following data is part of a premarket notification filed by Cryolife, Inc. with the FDA for Cryovalve Sg Pulmonary Valve And Conduit.
| Device ID | K083106 |
| 510k Number | K083106 |
| Device Name: | CRYOVALVE SG PULMONARY VALVE AND CONDUIT |
| Classification | Heart Valve, More Than Minimally Manipulated Allograft |
| Applicant | CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. Kennesaw, GA 30144 |
| Contact | John D Ferros |
| Correspondent | John D Ferros 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 | 2008-10-20 |
| Decision Date | 2009-02-06 |
| Summary: | summary |