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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K201792
Device Name TRUSELECT Microcatheter
Applicant
Boston Scientific Corporation
3 Scimed Place
Maple Grove,  MN  55311
Applicant Contact Aoife Tobin
Correspondent
Boston Scientific Corporation
3 Scimed Place
Maple Grove,  MN  55311
Correspondent Contact Aoife Tobin
Regulation Number870.1210
Classification Product Code
KRA  
Date Received06/30/2020
Decision Date 07/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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