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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 K160583
Device Name REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
Applicant
VOLCANO CORPORATION
3721 VALLEY CENTRE DRIVE SUITE 500
SAN DIEGO,  CA  92130
Applicant Contact BRIAN PARK
Correspondent
VOLCANO CORPORATION
3721 VALLEY CENTRE DRIVE SUITE 500
SAN DIEGO,  CA  92130
Correspondent Contact BRIAN PARK
Regulation Number870.1200
Classification Product Code
OBJ  
Subsequent Product Code
ITX  
Date Received03/01/2016
Decision Date 10/26/2016
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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