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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
CathWorks Ltd
3 Rapaport Street
Kfar-Saba,  IL 4465141
Applicant Contact Miriam Ivenshitz
Heyer Regulatory Solutions LLC
125 Cherry Lane
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number870.1415
Classification Product Code
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