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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 K161152
Device Name Navien Intracranial Support Catheter
Applicant
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 TOLEDO WAY
irvine,  CA  92618
Applicant Contact ingrid takeuchi
Correspondent
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 TOLEDO WAY
irvine,  CA  92618
Correspondent Contact jennifer correa
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/25/2016
Decision Date 10/12/2016
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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