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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K210235
Device Name Verrata PLUS Pressure Guide Wire
Applicant
Volcano Corporation
3721 Valley Centre Dr.., Suite 500
San Diego,  CA  92130
Applicant Contact Leilani Taylor
Correspondent
Volcano Corporation
3721 Valley Centre Dr.., Suite 500
San Diego,  CA  92130
Correspondent Contact Leilani Taylor
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
DXO  
Date Received01/28/2021
Decision Date 04/15/2021
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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