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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 K123621
Device Name OPTICROSS 40 MHZ CORONARY IMAGING CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
47215 LAKEVIEW BOULEVARD
FREMONT,  CA  94538
Applicant Contact ERIC ELLIOTT
Correspondent
BOSTON SCIENTIFIC CORP.
47215 LAKEVIEW BOULEVARD
FREMONT,  CA  94538
Correspondent Contact ERIC ELLIOTT
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received11/23/2012
Decision Date 04/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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