ACIST Medical Systems, Inc

FDA Filings

This page includes the latest FDA filings for ACIST Medical Systems, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
ACIST Medical Systems, Inc.
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter2020-03-20
ACIST Medical Systems, Inc.
ACIST RXi System And Navvus II Catheter2019-09-13
ACIST Medical Systems, Inc.
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit2019-07-18
ACIST Medical Systems, Inc.
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System2019-06-27
ACIST Medical Systems, Inc.
ACISTCVi® Contrast Delivery System2018-02-16
ACIST Medical Systems, Inc.
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System2017-10-23
ACIST Medical Systems, Inc.
ACIST RXi Mini System2017-08-18
ACIST MEDICAL SYSTEMS
CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER2014-01-30
ACIST MEDICAL SYSTEMS, INC.
ADAGIO RETRACTING ECG LEAD WIRES2010-01-15
ACIST MEDICAL SYSTEMS
ACIST PLUS 4 ANGIOGRAPHIC CATHETER2002-04-26
ACIST MEDICAL SYSTEMS, INC.
ACIST 4 FRENCH ANGIOGRAPHIC CATHETER2002-03-13
ACIST MEDICAL SYSTEMS
MODIFICATION TO ACIST CL 100H2000-05-31
ACIST MEDICAL SYSTEMS
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-20002000-03-28
ACIST MEDICAL SYSTEMS
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH1999-12-07
ACIST MEDICAL SYSTEMS
ACIST INJECTOR SYSTEM, MODEL CL100 H1999-02-11

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
ACIST Kodama® Coronary Imaging Catheter
ACIST MEDICAL SYSTEMS, INC.2020-03-04
ACIST CVi®1 Contrast Delivery System Injector Head
ACIST MEDICAL SYSTEMS, INC.2019-10-25
ACIST CVi®1 Contrast Delivery System Injector Head
ACIST MEDICAL SYSTEMS, INC.2019-10-25
ACIST CVi®1 Contrast Delivery System
ACIST MEDICAL SYSTEMS, INC.2019-10-25
ACIST CVi® Contrast Delivery System
ACIST MEDICAL SYSTEMS, INC.2019-10-25
Single-use Syringe Kit
ACIST MEDICAL SYSTEMS, INC.2019-10-24
AngioTouch® Kit
ACIST MEDICAL SYSTEMS, INC.2019-05-14
BT2000 Automated Manifold Kit
ACIST MEDICAL SYSTEMS, INC.2019-05-14
A2000 Multi-use Syringe Kit
ACIST MEDICAL SYSTEMS, INC.2019-05-14
Multi-use Syringe Kit
ACIST MEDICAL SYSTEMS, INC.2019-05-14
ACIST RXi® Mini System Overpack
ACIST MEDICAL SYSTEMS, INC.2019-05-14
A2000 Multi-use Syringe Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-15
AngioTouch® Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-15
ACIST CVi® Angiographic Injection System Control Panel
ACIST MEDICAL SYSTEMS, INC.2019-04-15
ACIST CVi® Angiographic Injection System Injector Head
ACIST MEDICAL SYSTEMS, INC.2019-04-15
ACIST CVi® Angiographic Injection System Injector Head
ACIST MEDICAL SYSTEMS, INC.2019-04-15
CPT2000 Automated Manifold Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-15
ACIST RXi® System and Accessories
ACIST MEDICAL SYSTEMS, INC.2019-04-15
B2000 Automated Manifold Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-15
ACIST CVi® Angiographic Injection System
ACIST MEDICAL SYSTEMS, INC.2019-04-15
AngioTouch® Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-15
ACIST CVi® Angiographic Injection System
ACIST MEDICAL SYSTEMS, INC.2019-04-15
AngioTouch® Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-15
AngioTouch® Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-15
A2000 Multi-use Syringe Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-15
BT2000 Automated Manifold Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-10
AngioTouch® Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-10
A2000 Multi-use Syringe Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-10
A2000 Multi-use Syringe Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-10
BT2000 Automated Manifold Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-10
BT2000 Automated Manifold Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-10
BT2000 Automated Manifold Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-10
AngioTouch® Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-10
AngioTouch® Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-10
AngioTouch® Kit
ACIST MEDICAL SYSTEMS, INC.2019-04-10

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