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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K170915
Device Name TXM Hydrophilic Guidewire
Applicant
Texasmedical Technologies, Inc.
9005 Montana Ave.
Suite A
El Paso,  TX  79925
Applicant Contact Aaron Chiu
Correspondent
Smith Associates
Crofton,  MD  21114
Correspondent Contact E. J. Smith
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/28/2017
Decision Date 11/21/2017
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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