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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 K211990
Device Name Rist 071 Radial Access Guide Catheter
Applicant
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Applicant Contact Amnon Talmor
Correspondent
Inneuroco, Inc.
19700 Sterling Rd., Suite 1
Pembroke Pines,  FL  33332
Correspondent Contact Marianne Grunwaldt
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
QJP  
Date Received06/28/2021
Decision Date 07/27/2021
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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