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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 K193183
Device Name ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
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 Angela Johnson
Regulation Number870.1200
Classification Product Code
OBJ  
Subsequent Product Code
IYO  
Date Received11/18/2019
Decision Date 03/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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