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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 Grove,  MN  55311 -1566
Applicant Contact Lori Berends
Correspondent
Boston Scientific Corporation
Three Scimed Place
Maple Grove,  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
Recalls CDRH Recalls
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