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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K153771
Device Name TXM Guiding Sheath
Applicant
Texasmedical Technologies, Inc.
9005 Montana Ave.
Suite A
El Paso,  TX  79925
Applicant Contact Aaron Chiu
Correspondent
Smith Assoicates
Crofton,  MD  21114
Correspondent Contact EJ Smith
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/30/2015
Decision Date 09/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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