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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K213303
Device Name Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42
Applicant
Infraredx, Inc.
28 Crosby Dr.
Suite 100
Bedford,  MA  01730
Applicant Contact Stephen Sum
Correspondent
Infraredx, Inc.
28 Crosby Dr.
Suite 100
Bedford,  MA  01730
Correspondent Contact Stephen Sum
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
OBJ   OGZ  
Date Received10/04/2021
Decision Date 12/07/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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