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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 K210230
Device Name Phenom Catheters
Applicant
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
9775 Toledo Way
Lrvine,  CA  92618
Applicant Contact Prerana Gurubasavaraj
Correspondent
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
9775 Toledo Way
Lrvine,  CA  92618
Correspondent Contact Prerana Gurubasavaraj
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Codes
KRA   QJP  
Date Received01/28/2021
Decision Date 02/25/2021
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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