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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Angiographic Coronary Vascular Physiologic Simulation Software
510(k) Number K182149
Device Name FFRangio System
Applicant
CathWorks Ltd
3 Rapaport Street
Kfar-Saba,  IL 4465141
Applicant Contact Miriam Ivenshitz
Correspondent
Heyer Regulatory Solutions LLC
125 Cherry Lane
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number870.1415
Classification Product Code
QEK  
Date Received08/08/2018
Decision Date 12/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT03226262
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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