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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K070487
Device Name SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
Applicant
Volcano Corporation
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Applicant Contact CYNTHIA VAN DUKER
Correspondent
Volcano Corporation
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Correspondent Contact CYNTHIA VAN DUKER
Regulation Number870.2870
Classification Product Code
DXO  
Date Received02/20/2007
Decision Date 03/16/2007
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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