Idev Technologies, Inc.
Houston, TX, US
Idev Technologies, Inc. appears in FDA device records in Houston, TX. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Idev Technologies, Inc. between 2003 and 2013. The busiest year on record is 2003, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 2 |
| 2005 | 2 |
| 2006 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130591 | SUPERA VERITAS | FGE | Unknown | |
| K122546 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | |
| K111627 | SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | |
| K111766 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS | FGE | Unknown | |
| K093893 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | |
| K071646 | SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120 | FGE | Unknown | |
| K060557 | SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060 | FGE | Unknown | |
| K050926 | TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060 | MMX | Substantially Equivalent | |
| K041374 | AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 | QEW | Substantially Equivalent | |
| K033188 | TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 | MMX | Substantially Equivalent | |
| K030504 | AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 | MCW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1550-2013 | IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms | There was an error on the outer labeling of this device. The inner label was correct. | Class II | Terminated | |
| Z-1213-2012 | SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms. | The firm is taking this action because the device was one of eight that may have been mislabeled with the incorrect size (length). | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Idev Technologies, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain