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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 K120697
Model 85900PST
Device Name EAGLE EYE PLATINUM ST CATHETER
Original Applicant
VOLCANO CORPORATION
3721 valley centre dr ste 500
san diego,  CA  92130
Original Contact marilyn pourazar
Regulation Number870.1200
Classification Product Code
OBJ  
Subsequent Product Code
ITX  
Date Received03/07/2012
Decision Date 04/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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