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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, Plaque Morphology Evaluation
510(k) Number K133897
Device Name TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
Applicant
Infraredx, Inc.
34 Third Ave.
Burlington,  MA  01803
Applicant Contact STEVEN J CHARTIER
Correspondent
Infraredx, Inc.
34 Third Ave.
Burlington,  MA  01803
Correspondent Contact STEVEN J CHARTIER
Regulation Number870.1200
Classification Product Code
OGZ  
Date Received12/20/2013
Decision Date 04/23/2014
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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