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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 K171913
Device Name Rubicon 14, 18 and 35 Support Catheters
Applicant
Boston Scientific Corporation
Three Scimed Place
Maple Grove,  MN  55311 -1566
Applicant Contact Ka Zoua Xiong
Correspondent
Boston Scientific Corporation
Three Scimed Place
Maple Grove,  MN  55311 -1566
Correspondent Contact Ka Zoua Xiong
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/26/2017
Decision Date 07/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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