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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 K180864
Device Name WATCHMAN TruSeal Access System
Applicant
Boston Scientific
Three Scimed Place
Maple Gove,  MN  55311 -1566
Applicant Contact Nikki M Ibis
Correspondent
Boston Scientific
Three Scimed Place
Maple Gove,  MN  55311 -1566
Correspondent Contact Nikki M Ibis
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/02/2018
Decision Date 07/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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