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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, continuous flush
510(k) Number K113289
Model 105-5098-150
Device Name ORION MICRO CATHETER
Original Applicant
MICRO THERAPEUTICS, INC.
9775 toledo way
irvine,  CA  92618
Original Contact analia nieto
Regulation Number870.1210
Classification Product Code
KRA  
Date Received11/07/2011
Decision Date 08/01/2012
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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