Known Identifiers & Locations
FEI Numbers
1016427
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 (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0003-2014 |
Cordis ADROIT 6F Guiding Catheter
Product Usage:
For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Reason: Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.
|
2013-08-12 |
Terminated
|
View Details
|
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