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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K140291
Device Name VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS
Applicant
Volcano Corporation
1 Fortune Dr.
Billerica,  MA  01821
Applicant Contact MARCUS GARCIA
Correspondent
Volcano Corporation
1 Fortune Dr.
Billerica,  MA  01821
Correspondent Contact MARCUS GARCIA
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
DSA   DSK  
Date Received02/05/2014
Decision Date 03/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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