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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Percutaneous Retrieval
510(k) Number K050926
Device Name TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060
Applicant
Idev Technologies, Inc.
1110 Nasa Rd. One
Suite 311
Houston,  TX  77058
Applicant Contact SHANNON HURD
Correspondent
Idev Technologies, Inc.
1110 Nasa Rd. One
Suite 311
Houston,  TX  77058
Correspondent Contact SHANNON HURD
Regulation Number870.5150
Classification Product Code
MMX  
Date Received04/13/2005
Decision Date 05/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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