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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K190078
Device Name IntraSight
Applicant
Volcano Corporation
3721 Valley Ctrre Dr. Suite 500
San Diego,  CA  92130
Applicant Contact Kimberly Simon
Correspondent
Volcano Corporation
3721 Valley Ctrre Dr. Suite 500
San Diego,  CA  92130
Correspondent Contact Kimberly Simon
Regulation Number870.2900
Classification Product Code
DSA  
Subsequent Product Codes
DSK   IYO  
Date Received01/16/2019
Decision Date 02/11/2019
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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