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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, angioplasty, peripheral, transluminal
510(k) Number K120677
Device Name CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014")
Original Applicant
TRIREME MEDICAL INC
7060 knoll center parkway
suite 300
pleasanton,  CA  94566
Original Contact shiva ardakani
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received03/06/2012
Decision Date 03/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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