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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 K080891
Device Name REVOLUTION 45MHZ IVUS IMAGING CATHETER
Applicant
Volcano Corporation
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Applicant Contact JENNIFER MOTTO
Correspondent
Volcano Corporation
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Correspondent Contact JENNIFER MOTTO
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received03/31/2008
Decision Date 05/12/2008
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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