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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 K143701
Device Name EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM
Applicant
Volcano Corporation
3721 Valley Centre Dr., Suite 500
San Diego,  CA  92130
Applicant Contact MARCUS GARCIA
Correspondent
Volcano Corporation
1 Fortune Dr.
Billerica,  MA  01821
Correspondent Contact Elaine Alan
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received12/24/2014
Decision Date 08/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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