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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 K190401
Device Name MAMBA and MAMBA Flex Microcatheters
Applicant
Boston Scientific Corporation
Three Scimed Place
Maple Grove Hennepin,  MN  55311
Applicant Contact Kevin Catalano
Correspondent
Boston Scientific Corporation
Three Scimed Place
Maple Grove Hennepin,  MN  55311
Correspondent Contact Kevin Catalano
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/19/2019
Decision Date 03/15/2019
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
Recalls CDRH Recalls
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