Idev Technologies, Inc.
Medical device manufacturer in Webster, TX.
11510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K130591 | Supera VeritasFGE · Traditional | 05/02/2013SESU |
| K122546 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemFGE · Traditional | 12/07/2012SESU |
| K111627 | Supera Veritas(R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemFGE · Traditional | 08/21/2012SESU |
| K111766 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsFGE · Traditional | 10/19/2011SESU |
| K093893 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemFGE · Traditional | 10/05/2010SESU |
| K071646 | Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model #…FGE · Traditional | 01/31/2008SESU |
| K060557 | Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery CATHETER-SS06120060FGE · Traditional | 08/15/2006SESU |
| K050926 | Texan Longhorn Foreign Body Retrieval Device, Model TX30120060MMX · Special | 05/09/2005SE |
| K041374 | Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060QEW · Traditional | 03/02/2005SE |
| K033188 | Texan Foreign Body Retrieval Device, Model TX30060050MMX · Traditional | 11/19/2003SE |
| K030504 | Akonya Eliminator Mechanical Thrombectomy Device, Model El 10060060MCW · Traditional | 09/16/2003SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1550-2013 Class II | IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic…There was an error on the outer labeling of this device. The inner label was correct. | 05/29/2012Terminated |
| Z-1213-2012 | SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System.…The firm is taking this action because the device was one of eight that may have been mislabeled with the… | 01/31/2012Terminated |