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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 K153094
Device Name Visions PV .035 Digital IVUS Catheter
Applicant
Volcano Corporation
3721 Valley Centre Dr., Suite 500
San Diego,  CA  92130
Applicant Contact Neeta Sharma
Correspondent
Volcano Corporation
3721 Valley Centre Dr., Suite 500
San Diego,  CA  92130
Correspondent Contact Neeta Sharma
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received10/26/2015
Decision Date 12/31/2015
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
Recalls CDRH Recalls
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