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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K191175
Device Name ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
Applicant
Acist Medical Systems, Inc.
7905 Fuller Rd.
Eden Prairie,  MN  55344
Applicant Contact Angela Johnson
Correspondent
Acist Medical Systems, Inc.
7905 Fuller Rd.
Eden Prairie,  MN  55344
Correspondent Contact Matt Stepanek
Regulation Number870.1200
Classification Product Code
OBJ  
Subsequent Product Code
IYO  
Date Received05/01/2019
Decision Date 06/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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