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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K260771
Device Name TruSelect™ 2.6 Microcatheter
Applicant
Boston Scientific Corporation
300 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact Rosemary Bushby
Correspondent
Boston Scientific Corporation
300 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact Rosemary Bushby
Regulation Number870.1210
Classification Product Code
KRA  
Date Received03/09/2026
Decision Date 05/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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