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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 K100930
Device Name PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J
Applicant
Volcano Corporation
3661 Valley Center Dr.
Suite 200
San Diego,  CA  92130
Applicant Contact MARILYN POURAZAR
Correspondent
Volcano Corporation
3661 Valley Center Dr.
Suite 200
San Diego,  CA  92130
Correspondent Contact MARILYN POURAZAR
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/05/2010
Decision Date 04/30/2010
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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