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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 K173284
Device Name OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)
Applicant
Boston Scientific Corporation
47215 Lakeview Blvd.
Fremont,  CA  94538
Applicant Contact Mugdha Dongre
Correspondent
Boston Scientific Corporation
47215 Lakeview Blvd.
Fremont,  CA  94538
Correspondent Contact Mugdha Dongre
Regulation Number870.1200
Classification Product Code
OBJ  
Subsequent Product Code
ITX  
Date Received10/16/2017
Decision Date 11/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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