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IDEV Technologies, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
11
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1550-2013Class IIIDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemMay 29, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K130591SUPERA VERITASMay 2, 2013
K122546SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEMDecember 7, 2012
K111627SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEMAugust 21, 2012
K111766SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMSOctober 19, 2011
K093893SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEMOctober 5, 2010
K071646SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120January 31, 2008
K060557SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060August 15, 2006
K050926TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060May 9, 2005
K041374AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060March 2, 2005
K033188TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050November 19, 2003
K030504AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060September 16, 2003