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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 K202318
Device Name Marathon Flow Directed Micro Catheter
Applicant
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Applicant Contact Elizabeth Campion
Correspondent
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Correspondent Contact Elizabeth Campion
Regulation Number870.1210
Classification Product Code
KRA  
Subsequent Product Code
QJP  
Date Received08/17/2020
Decision Date 09/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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