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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 K162789
Device Name Foresight Intracardiac Echocardiology (ICE) System
Applicant
Conavi Medical Inc.
293 Lesmill Road
Toronto,  CA M3B 2V1
Applicant Contact Sam Mostafavi
Correspondent
Conavi Medical Inc.
293 Lesmill Road
Toronto,  CA M3B 2V1
Correspondent Contact Sam Mostafavi
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
ITX  
Date Received10/04/2016
Decision Date 03/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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