ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

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 Kodama Intravascular Ultrasound Catheter, Acist Hdi System.

Pre-market Notification Details

Device IDK191175
510k NumberK191175
Device Name:ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
ClassificationCatheter, Ultrasound, Intravascular
Applicant ACIST Medical Systems, Inc. 7905 Fuller Rd. Eden Prairie,  MN  55344
ContactAngela Johnson
CorrespondentMatt Stepanek
ACIST Medical Systems, Inc. 7905 Fuller Rd. Eden Prairie,  MN  55344
Product CodeOBJ  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-01
Decision Date2019-06-27

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