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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 K191551
Device Name RIST Cath Radial Access Long Sheath
Applicant
Rist Neurovascular, Inc.
11611 Interchange Circle S.
Miramar,  FL  33025
Applicant Contact Marianne Grumwaldt
Correspondent
Caraballo Consulting
11037 Bitternut Hickory Lane
Boynton Beach,  FL  33437
Correspondent Contact Elena Jugo
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/12/2019
Decision Date 12/23/2019
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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