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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 K071660
Device Name VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900
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 Received06/18/2007
Decision Date 08/31/2007
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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