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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 K121273
Device Name VISIONS PV .035 DITITAL IVUS 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  
Date Received04/27/2012
Decision Date 09/10/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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