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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, Neurovasculature
510(k) Number K200417
Device Name RIST Radial Access Catheter
Applicant
Rist Neurovascular, Inc.
11611 Interchange Cir. S.
Miramar,  FL  33025
Applicant Contact Marianne Grumwaldt
Correspondent
Rist Neurovascular, Inc.
11611 Interchange Cir. S.
Miramar,  FL  33025
Correspondent Contact Vyoma Upadhya Chikara
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received02/20/2020
Decision Date 05/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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