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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K142817
Device Name IntraNovo 25 Microcatheter
Applicant
Texasmedical Technologies, Inc.
9005 Montana Ave.
Suite A
El Paso,  TX  79925
Applicant Contact Aaron Chiu
Correspondent
Pomamed Consulting, LLC
P.O. Box 9818
San Juan,  PR  00908
Correspondent Contact Viviana I Gonzalez
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/29/2014
Decision Date 04/23/2015
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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