The following data is part of a premarket notification filed by Cryolife, Inc. with the FDA for Cryovalve Sg Pulmonary Human Heart Valve (and Conduit).
| Device ID | K092021 |
| 510k Number | K092021 |
| Device Name: | CRYOVALVE SG PULMONARY HUMAN HEART 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 | 2009-07-06 |
| Decision Date | 2010-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877234000454 | K092021 | 000 |
| 00877234000447 | K092021 | 000 |