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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 K151126
Device Name Foresight Intracardiac Echocardiography (ICE) System
Applicant
Colibri Technologies, Inc.
293 Lesmill Rd.
Toronto,  CA M3B2V1
Applicant Contact SAM MOSTAFAVI
Correspondent
Colibri Technologies, Inc.
293 Lesmill Rd.
Toronto,  CA M3B2V1
Correspondent Contact SAM MOSTAFAVI
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Codes
ITX   IYO   ORD  
Date Received04/28/2015
Decision Date 12/18/2015
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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