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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 K192886
Device Name OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
Applicant
Volcano Corporation
3721 Valley Centre Dr., Suite 500
San Diego,  CA  92130
Applicant Contact Jenny Fu
Correspondent
Volcano Corporation
3721 Valley Centre Dr., Suite 500
San Diego,  CA  92130
Correspondent Contact Jenny Fu
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
DXO  
Date Received10/10/2019
Decision Date 03/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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