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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
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 (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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