Known Identifiers & Locations
FEI Numbers
3001451326
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0019-04 |
CryoValve, Pulmonary Valve & Conduit SG
Reason: The heart valve procurement exceeded the warm ischemic time criteria.
|
2003-08-18 |
Terminated
|
View Details
|
| Z-0026-05 |
CryoValve, Pulmonary Valve & Conduit
Reason: A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus.
|
2004-07-15 |
Terminated
|
View Details
|
Profile Disclaimer
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.