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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K260816
Device Name OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)
Applicant
Boston Scientific
1 Boston Scientific Way
Maple Grove,  MN  55369
Applicant Contact Brian Li
Correspondent
Boston Scientific
1 Boston Scientific Way
Maple Grove,  MN  55369
Correspondent Contact Brian Li
Regulation Number870.1200
Classification Product Code
OBJ  
Subsequent Product Code
ITX  
Date Received03/13/2026
Decision Date 04/08/2026
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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