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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
Lrvine,  CA  92618
Applicant Contact Elizabeth Campion
Correspondent
Micro Therapeutics Inc., d/b/a ev3 Neurovascular
9775 Toledo Way
Lrvine,  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
Predetermined Change
Control Plan Authorized		 No
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