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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter for crossing total occlusions
510(k) Number K122380
Model O100, L100, Y100
Device Name OCELOT SYSTEM
Original Applicant
AVINGER, INC.
400 chesapeake drive
redwood city,  CA  94063
Original Contact albert boniske
Regulation Number870.1250
Classification Product Code
PDU  
Date Received08/06/2012
Decision Date 11/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Clinical Trials NCT01537302
Reviewed by Third Party No
Expedited Review No
Combination Product No
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