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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 K161125
Device Name OptiCross X, 40 MHz Coronary Imaging Catheter
Applicant
Boston Scientific Corporation
47215 Lakeview Blvd.
Fremont,  CA  94538
Applicant Contact Eric Elliott
Correspondent
Boston Scientific Corporation
47215 Lakeview Blvd.
Fremont,  CA  94538
Correspondent Contact Eric Elliott
Regulation Number870.1200
Classification Product Code
OBJ  
Subsequent Product Code
ITX  
Date Received04/21/2016
Decision Date 05/19/2016
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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