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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 K223633
Device Name Rubicon™ Control Support Catheter (H749394323506A1)
Applicant
Boston Scientific Corporation
One Scimed Place
Maple Grove
Maple Grove,  MN  55311 -1566
Applicant Contact Mary-Jo Foley
Correspondent
Boston Scientific Corporation
One Scimed Place
Maple Grove
Maple Grove,  MN  55311 -1566
Correspondent Contact Mary-Jo Foley
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LOX  
Date Received12/05/2022
Decision Date 08/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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