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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K160173
Device Name Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
Applicant
Boston Scientific Corporation
47215 Lakeview Blvd.
Fremont,  CA  94538
Applicant Contact Eric Elliott
Correspondent
Boston Scientific Corporation
47215 Lakeview Blvd.
Fremont,  CA  94538
Correspondent Contact Eric Elliott
Regulation Number870.2330
Classification Product Code
DXK  
Subsequent Product Code
ITX  
Date Received01/27/2016
Decision Date 02/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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