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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K112579
Model W550
Device Name WILDCAT 5F GUIDEWIRE SUPPORT CATHETER
Original Applicant
AVINGER, INC.
400 chesapeake drive
redwood city,  CA  94063
Original Contact sevrina ciucci
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/06/2011
Decision Date 10/06/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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