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U.S. Department of Health and Human Services

Devices@FDA
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Device Classification Name catheter, thrombus retriever
510(k) Number K113455
Device Name SOLITAIRE FR REVASCULARIZATION DEVICE
Applicant
MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR
9775 TOLEDO WAY
IRVINE,  CA  92618
Applicant Contact Laura Heaton
Correspondent
MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR
9775 TOLEDO WAY
IRVINE,  CA  92618
Correspondent Contact Laura Heaton
Regulation Number870.1250
Classification Product Code
NRY  
Date Received11/21/2011
Decision Date 03/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT01054560
Reviewed by Third Party No
Combination Product No
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