Acist Medical Systems Inc

FDA Filings

This page includes the latest FDA filings for Acist Medical Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Acist Medical Systems Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number2134243
FEI Number3001726808
NameACIST MEDICAL SYSTEMS, INC.
Owner & OperatorACIST MEDICAL SYSTEMS, INC.
Contact Address7905 FULLER RD. --
Eden Prairie MN 55344 US
Official Correspondent
  • Jennifer Zwiefelhofer
  • x-952-9959357-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7905 FULLER ROAD
EDEN PRAIRIE, MN 55344 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
ACIST Medical Systems, Inc.
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System2020-12-17
ACIST MEDICAL SYSTEMS, INC.
Single-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
A1000 Single Use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
A2000 Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
A2000 Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
A2000 Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
A2000 Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
A2000 Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
A2000 Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
A2000 Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
A2000 Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
A2000 Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
A2000 Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
A2000 Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
A2000 Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
A2000 Multi-use Syringe Kit 2020-04-20
ACIST MEDICAL SYSTEMS, INC.
ACIST Kodama? Intravascular Ultrasound Catheter2020-03-30
ACIST MEDICAL SYSTEMS, INC.
ACIST HDi System2020-03-30
ACIST MEDICAL SYSTEMS, INC.
ACIST Kodama? Intravascular Ultrasound Catheter2020-03-30
ACIST MEDICAL SYSTEMS, INC.
ACIST HDi System2020-03-30
ACIST Medical Systems, Inc.
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter2020-03-20
ACIST MEDICAL SYSTEMS, INC.
ACIST Kodama® Coronary Imaging Catheter 2020-03-04
ACIST MEDICAL SYSTEMS, INC.
ACIST Rapid Exchange System (RXi) and Navvus II MicroCatheter2019-12-04
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi®1 Contrast Delivery System 2019-10-25
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi® Contrast Delivery System 2019-10-25
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi®1 Contrast Delivery System Injector Head 2019-10-25
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi®1 Contrast Delivery System Injector Head 2019-10-25
ACIST MEDICAL SYSTEMS, INC.
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System2019-09-24
ACIST MEDICAL SYSTEMS, INC.
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System2019-09-24
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi?1 Contrast Delivery System2019-09-24
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.
ACIST RXi® Mini System Overpack 2019-05-14
ACIST MEDICAL SYSTEMS, INC.
AngioTouch® Kit 2019-05-14
ACIST MEDICAL SYSTEMS, INC.
BT2000 Automated Manifold Kit 2019-05-14
ACIST MEDICAL SYSTEMS, INC.
ACIST RXi® System and Accessories 2019-04-15
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi® Angiographic Injection System 2019-04-15
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi® Angiographic Injection System 2019-04-15
ACIST MEDICAL SYSTEMS, INC.
AngioTouch® Kit 2019-04-15
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi® Angiographic Injection System Control Panel 2019-04-15
ACIST MEDICAL SYSTEMS, INC.
CPT2000 Automated Manifold Kit 2019-04-15
ACIST MEDICAL SYSTEMS, INC.
B2000 Automated Manifold Kit 2019-04-15
ACIST MEDICAL SYSTEMS, INC.
AngioTouch® Kit 2019-04-15
ACIST MEDICAL SYSTEMS, INC.
AngioTouch® Kit 2019-04-15
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi® Angiographic Injection System Injector Head 2019-04-15
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi® Angiographic Injection System Injector Head 2019-04-15
ACIST MEDICAL SYSTEMS, INC.
AngioTouch® Kit 2019-04-15
ACIST MEDICAL SYSTEMS, INC.
AngioTouch® Kit 2019-04-10
ACIST MEDICAL SYSTEMS, INC.
BT2000 Automated Manifold Kit 2019-04-10
ACIST MEDICAL SYSTEMS, INC.
BT2000 Automated Manifold Kit 2019-04-10
ACIST MEDICAL SYSTEMS, INC.
BT2000 Automated Manifold Kit 2019-04-10
ACIST MEDICAL SYSTEMS, INC.
BT2000 Automated Manifold Kit 2019-04-10
ACIST MEDICAL SYSTEMS, INC.
BT2000 Automated Manifold Kit 2019-04-10
ACIST MEDICAL SYSTEMS, INC.
AngioTouch® Kit 2019-04-10
ACIST MEDICAL SYSTEMS, INC.
AngioTouch® Kit 2019-04-10
ACIST MEDICAL SYSTEMS, INC.
AngioTouch® Kit 2019-04-10
ACIST MEDICAL SYSTEMS, INC.
AngioTouch® Kit 2019-04-10
ACIST MEDICAL SYSTEMS, INC.
AngioTouch® Kit 2019-04-10
ACIST MEDICAL SYSTEMS, INC.
AngioTouch® Kit 2019-04-10
ACIST MEDICAL SYSTEMS, INC.
AngioTouch® Kit 2019-04-10
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2019-02-18
ACIST MEDICAL SYSTEMS, INC.
ACIST HDi® HD IVUS System 2018-12-31
ACIST MEDICAL SYSTEMS, INC.
ACIST HDi® HD IVUS System 2018-12-31
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-10-29
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-10-29
ACIST MEDICAL SYSTEMS, INC.
ACIST HDi® HD IVUS System 2018-10-05
ACIST MEDICAL SYSTEMS, INC.
ACIST HDi® HD IVUS System 2018-10-01
ACIST MEDICAL SYSTEMS, INC.
ACIST RXi® System and Accessories 2018-09-03
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi® Contrast Delivery System 2018-07-16
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi® Contrast Delivery System 2018-07-16
ACIST MEDICAL SYSTEMS, INC.
ACIST RXi® System and Accessories 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
ACIST RXi® System and Accessories 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
ACIST RXi® Console, Refurbished 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
ACIST RXi® System and Accessories 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
CVi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Mini Navvus Interface Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Mini Navvus Interface Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Mini Navvus Interface Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
RXi® Cable 2018-07-06
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi? Contrast Delivery System2018-03-08
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi? BT2000 Manifold Kit2018-03-08
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi? AngioTouch? Kit AT P652018-03-08
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi? AngioTouch? Kit AT P542018-03-08
ACIST MEDICAL SYSTEMS, INC.
ACIST CVi? A2000 Syringe Kit2018-03-08
ACIST Medical Systems, Inc.
ACISTCVi® Contrast Delivery System2018-02-16
ACIST MEDICAL SYSTEMS, INC.
ACIST Kodama? Intravascular Ultrasound Catheter2017-10-30
ACIST MEDICAL SYSTEMS, INC.
ACIST HDi? System2017-10-30
ACIST MEDICAL SYSTEMS, INC.
ACIST Kodama? Intravascular Ultrasound Catheter2017-10-30
ACIST MEDICAL SYSTEMS, INC.
ACIST HDi? System2017-10-30
ACIST Medical Systems, Inc.
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System2017-10-23
ACIST MEDICAL SYSTEMS, INC.
ACIST RXi Mini System and Accessories2017-09-21
ACIST Medical Systems, Inc.
ACIST RXi Mini System2017-08-18
ACIST MEDICAL SYSTEMS, INC.
ACIST Connect2016-08-15
ACIST MEDICAL SYSTEMS, INC.
A2000 Multi-use Syringe Kit, A2000V Multi-use Syringe Kit, B/BT2000 Automated Manifold Kit2014-08-04
ACIST MEDICAL SYSTEMS, INC.
CPT2000 Automated Manifold Kit2014-08-04
ACIST MEDICAL SYSTEMS, INC.
AngioTouch Handcontroller Kits (Models ATP54, ATP65, ATR54, ATL65)2014-08-04
ACIST MEDICAL SYSTEMS, INC.
Rapid Exchange (RXi) System2014-03-10
ACIST MEDICAL SYSTEMS, INC.
Navvus Catheter2014-03-10
ACIST MEDICAL SYSTEMS, INC.
Rapid Exchange (RXi) System2014-03-10
ACIST MEDICAL SYSTEMS, INC.
Navvus Catheter2014-03-10
ACIST MEDICAL SYSTEMS, INC.
ADAGIO RETRACTING ECG LEAD WIRES2010-01-15
ACIST MEDICAL SYSTEMS, INC.
EmpowerCTA Injector System (Empower Sync Remote)2008-07-10
ACIST MEDICAL SYSTEMS, INC.
EmpowerCTA Injector System (Empower Sync Remote)2008-07-10
ACIST MEDICAL SYSTEMS, INC.
EmpowerCTA Injector System (Empower Sync Remote)2008-07-10
ACIST MEDICAL SYSTEMS, INC.
EmpowerCTA/EmpowerCTA+2008-07-10
ACIST MEDICAL SYSTEMS, INC.
EmpowerCTA/EmpowerCTA+2008-07-10
ACIST MEDICAL SYSTEMS, INC.
EmpowerCTA/EmpowerCTA+2008-07-10
ACIST MEDICAL SYSTEMS, INC.
EmpowerCTA/EmpowerCTA+2008-07-10
ACIST MEDICAL SYSTEMS, INC.
C2000 AUTOMATED MANIFOLD KIT2005-12-16
ACIST MEDICAL SYSTEMS, INC.
ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS2004-03-15
ACIST MEDICAL SYSTEMS, INC.
ACIST 4 FRENCH ANGIOGRAPHIC CATHETER2002-03-13
ACIST MEDICAL SYSTEMS, INC.
CVI INJECTION SYSTEM2002-01-14
ACIST MEDICAL SYSTEMS, INC.
CMS20002002-01-14
ACIST MEDICAL SYSTEMS, INC.
E2000 VOYAGER2002-01-14
ACIST MEDICAL SYSTEMS, INC.
CVi2002-01-14
ACIST MEDICAL SYSTEMS, INC.
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS2001-03-09

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