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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 K113838
Models J100, W400
Device Name WILDCAT CATHETER
Applicant
AVINGER, INC.
400 chesapeake drive
redwood city,  CA  94063
Contact sevrina ciucci
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/28/2011
Decision Date 03/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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