Company ยท US
Idev Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2013. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 2, 2013 | K130591 | SUPERA VERITAS Idev Technologies, Inc. | FGE |
| Dec 7, 2012 | K122546 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Idev Technologies, Inc. | FGE |
| Aug 21, 2012 | K111627 | SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Idev Technologies, Inc. | FGE |
| Oct 19, 2011 | K111766 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS Idev Technologies, Inc. | FGE |
| Oct 5, 2010 | K093893 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Idev Technologies, Inc. | FGE |
| Jan 31, 2008 | K071646 | SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120 Idev Technologies, Inc. | FGE |
| Aug 15, 2006 | K060557 | SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060 Idev Technologies, Inc. | FGE |
| May 9, 2005 | K050926 | TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060 Idev Technologies, Inc. | MMX |
| Mar 2, 2005 | K041374 | AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 Idev Technologies, Inc. | QEW |
| Nov 19, 2003 | K033188 | TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 Idev Technologies, Inc. | MMX |
| Sep 16, 2003 | K030504 | AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 Idev Technologies, Inc. | MCW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2013 | IDEV Technologies, Inc. IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms Terminated |
FGE | K111766 |
| Mar 15, 2012 | Idev Technologies, Inc. SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System.
Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms. Terminated |
FGE | K093893 |