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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K172453
Device Name WATCHDOG Hemostasis Valve Kit
Applicant
Boston Scientific Corporation
Three Scimed Place
Maple Gove,  MN  55311 -1566
Applicant Contact Lori Berends
Correspondent
Boston Scientific Corporation
Three Scimed Place
Maple Gove,  MN  55311 -1566
Correspondent Contact Lori Berends
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
DTL  
Date Received08/14/2017
Decision Date 11/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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