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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 K181042
Device Name Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
Applicant
Boston Scientific Corporation
3 Scimed Place
Maple Grove,  MN  55311
Applicant Contact Jennifer L. Foley
Correspondent
Boston Scientific Corporation
3 Scimed Place
Maple Grove,  MN  55311
Correspondent Contact Jennifer L. Foley
Regulation Number870.2330
Classification Product Code
DXK  
Subsequent Product Code
ITX  
Date Received04/19/2018
Decision Date 05/17/2018
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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