ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter

Catheter, Ultrasound, Intravascular

ACIST Medical Systems, Inc.

The following data is part of a premarket notification filed by Acist Medical Systems, Inc. with the FDA for Acist Hdi System, Acist Kodama Intravascular Ultrasound Catheter.

Pre-market Notification Details

Device IDK193183
510k NumberK193183
Device Name:ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
ClassificationCatheter, Ultrasound, Intravascular
Applicant ACIST Medical Systems, Inc. 7905 Fuller Rd Eden Prairie,  MN  55344
ContactAngela Johnson
CorrespondentAngela Johnson
ACIST Medical Systems, Inc. 7905 Fuller Rd Eden Prairie,  MN  55344
Product CodeOBJ  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-18
Decision Date2020-03-20

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.