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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K171452
Device Name MAMBA and MAMBA FLEX Microcatheters
Applicant
Boston Scientific Corporation
Three Scimed Place
Maple Grove,  MN  55311
Applicant Contact Sherry Kollmann
Correspondent
Boston Scientific Corporation
Three Scimed Place
Maple Grove,  MN  55311
Correspondent Contact Sherry Kollmann
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/17/2017
Decision Date 08/21/2017
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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