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:

• FUJIKURA FIBER OPTICS VIETNAM LTD

FDA Registration(s)

• Registration Number: 2134243
• FEI Number: 3001726808
• Name: ACIST MEDICAL SYSTEMS, INC.
• Owner & Operator: ACIST MEDICAL SYSTEMS, INC.
• Contact Address: 7905 FULLER RD. --; Eden Prairie MN 55344 US
• Official Correspondent:
  • Jennifer Zwiefelhofer
  • x-952-9959357-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 7905 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	Device	Date
GUDID 30841716101732 ACIST MEDICAL SYSTEMS, INC.	ACIST RXi® System	2024-06-12
GUDID 30841716100384 ACIST MEDICAL SYSTEMS, INC.	ACIST RXi® System	2024-06-12
GUDID 20841716100004 ACIST MEDICAL SYSTEMS, INC.	ACIST Navvus® Catheter	2024-06-12
GUDID 10841716100014 ACIST MEDICAL SYSTEMS, INC.	ACIST Navvus® Catheter	2024-06-12
GUDID 10841716103251 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2024-06-07
GUDID 10841716102421 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2024-06-07
GUDID 30841716102524 ACIST MEDICAL SYSTEMS, INC.	A1000V Single Use Syringe Kit	2024-06-05
GUDID 30841716100070 ACIST MEDICAL SYSTEMS, INC.	ACIST CVi® Cart	2024-05-31
GUDID 30841716102616 ACIST MEDICAL SYSTEMS, INC.	Single-use Syringe Kit	2024-05-29
GUDID 30841716102609 ACIST MEDICAL SYSTEMS, INC.	A1000 Single Use Syringe Kit	2024-05-27
GUDID 30841716102548 ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit	2024-05-17
GUDID 10841716101349 ACIST MEDICAL SYSTEMS, INC.	ACIST CVi® Angiographic Injection System Injector Head	2024-05-17
GUDID 10841716101233 ACIST MEDICAL SYSTEMS, INC.	ACIST CVi® Angiographic Injection System Injector Head	2024-05-17
GUDID 10841716101196 ACIST MEDICAL SYSTEMS, INC.	ACIST CVi® Angiographic Injection System Control Panel	2024-05-17
GUDID 10841716100632 ACIST MEDICAL SYSTEMS, INC.	ACIST CVi® Angiographic Injection System Power Supply	2024-05-17
GUDID 30841716101596 ACIST MEDICAL SYSTEMS, INC.	ACIST HDi® Patient Interface Module (PIM)	2024-05-09
GUDID 30841716101176 ACIST MEDICAL SYSTEMS, INC.	ACIST HDi® Power Supply	2024-05-09
GUDID 30841716100698 ACIST MEDICAL SYSTEMS, INC.	ACIST HDi® Linear Translation System (LTS)	2024-05-09
GUDID 30841716100254 ACIST MEDICAL SYSTEMS, INC.	ACIST HDi® System Console	2024-05-09
GUDID 10841716102148 ACIST MEDICAL SYSTEMS, INC.	ACIST HDi® System Console	2024-05-09
GUDID 10841716101851 ACIST MEDICAL SYSTEMS, INC.	ACIST HDi® System Console	2024-05-09
GUDID 30841716101206 ACIST MEDICAL SYSTEMS, INC.	ACIST HDi® Cart	2024-04-22
GUDID 30841716100773 ACIST MEDICAL SYSTEMS, INC.	ACIST HDi® Bed Rail Mount	2024-04-22
GUDID 30841716102005 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2022-09-16
GUDID 30841716101992 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2022-09-16
GUDID 30841716101381 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2022-09-16
GUDID 30841716101374 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2022-09-16
GUDID 30841716101367 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2022-09-16
GUDID 30841716101312 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2022-09-16
GUDID 30841716101305 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2022-09-16
GUDID 30841716101299 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2022-09-16
GUDID 30841716101282 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2022-09-16
GUDID 30841716100780 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2022-09-16
GUDID 30841716100353 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2022-09-16
GUDID 30841716100216 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2022-09-16
GUDID 30841716100179 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2022-09-16
GUDID 30841716100155 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2022-09-16
GUDID 30841716102845 ACIST MEDICAL SYSTEMS, INC.	RXi® Console Cable	2021-06-25
GUDID 30841716101978 ACIST MEDICAL SYSTEMS, INC.	BT2000 Automated Manifold Kit	2021-02-19
GUDID 30841716101565 ACIST MEDICAL SYSTEMS, INC.	BT2000 Automated Manifold Kit	2021-02-19
GUDID 30841716100346 ACIST MEDICAL SYSTEMS, INC.	CPT2000 Automated Manifold Kit	2021-02-19
GUDID 30841716100315 ACIST MEDICAL SYSTEMS, INC.	BT2000 Automated Manifold Kit	2021-02-19
GUDID 30841716100292 ACIST MEDICAL SYSTEMS, INC.	BT2000 Automated Manifold Kit	2021-02-19
GUDID 30841716100285 ACIST MEDICAL SYSTEMS, INC.	BT2000 Automated Manifold Kit	2021-02-19
GUDID 30841716100278 ACIST MEDICAL SYSTEMS, INC.	BT2000 Automated Manifold Kit	2021-02-19
PMN K203004 ACIST Medical Systems, Inc.	ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System	2020-12-17
GUDID 30841716102166 ACIST MEDICAL SYSTEMS, INC.	Single-use Syringe Kit	2020-04-20
GUDID 30841716102159 ACIST MEDICAL SYSTEMS, INC.	A1000 Single Use Syringe Kit	2020-04-20
GUDID 30841716102111 ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit	2020-04-20
GUDID 30841716101947 ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit	2020-04-20
GUDID 30841716101916 ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit	2020-04-20
GUDID 30841716101633 ACIST MEDICAL SYSTEMS, INC.	Multi-use Syringe Kit	2020-04-20
GUDID 30841716101534 ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit	2020-04-20
GUDID 30841716101527 ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit	2020-04-20
GUDID 30841716101268 ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit	2020-04-20
GUDID 30841716100087 ACIST MEDICAL SYSTEMS, INC.	Multi-use Syringe Kit	2020-04-20
GUDID 30841716100063 ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit	2020-04-20
GUDID 30841716100056 ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit	2020-04-20
GUDID 30841716100049 ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit	2020-04-20
GUDID 30841716100032 ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit	2020-04-20
GUDID 10841716101684 ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit	2020-04-20
GUDID 10841716101271 ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit	2020-04-20
GUDID 10841716100021 ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit	2020-04-20
PMN K193183 | OBJ ACIST MEDICAL SYSTEMS, INC.	ACIST Kodama? Intravascular Ultrasound Catheter	2020-03-30
PMN K193183 | OBJ ACIST MEDICAL SYSTEMS, INC.	ACIST HDi System	2020-03-30
PMN K193183 | IYO ACIST MEDICAL SYSTEMS, INC.	ACIST Kodama? Intravascular Ultrasound Catheter	2020-03-30
PMN K193183 | IYO ACIST MEDICAL SYSTEMS, INC.	ACIST HDi System	2020-03-30
PMN K193183 ACIST Medical Systems, Inc.	ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter	2020-03-20
GUDID 10841716100755 ACIST MEDICAL SYSTEMS, INC.	ACIST Kodama® Coronary Imaging Catheter	2020-03-04
PMN K190473 | OBI ACIST MEDICAL SYSTEMS, INC.	ACIST Rapid Exchange System (RXi) and Navvus II MicroCatheter	2019-12-04
GUDID 40841716102200 ACIST MEDICAL SYSTEMS, INC.	ACIST CVi®1 Contrast Delivery System	2019-10-25
GUDID 40841716102194 ACIST MEDICAL SYSTEMS, INC.	ACIST CVi® Contrast Delivery System	2019-10-25
GUDID 10841716102209 ACIST MEDICAL SYSTEMS, INC.	ACIST CVi®1 Contrast Delivery System Injector Head	2019-10-25
GUDID 10841716102193 ACIST MEDICAL SYSTEMS, INC.	ACIST CVi®1 Contrast Delivery System Injector Head	2019-10-25
PMN K191175 | OBJ ACIST MEDICAL SYSTEMS, INC.	ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System	2019-09-24
PMN K191175 | IYO ACIST MEDICAL SYSTEMS, INC.	ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System	2019-09-24
PMN K191060 | DXT ACIST MEDICAL SYSTEMS, INC.	ACIST CVi?1 Contrast Delivery System	2019-09-24
PMN K190473 ACIST Medical Systems, Inc.	ACIST RXi System And Navvus II Catheter	2019-09-13
PMN K191060 ACIST Medical Systems, Inc.	ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit	2019-07-18
PMN K191175 ACIST Medical Systems, Inc.	ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System	2019-06-27
GUDID 40841716101586 ACIST MEDICAL SYSTEMS, INC.	ACIST RXi® Mini System Overpack	2019-05-14
GUDID 30841716102135 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2019-05-14
GUDID 30841716102128 ACIST MEDICAL SYSTEMS, INC.	BT2000 Automated Manifold Kit	2019-05-14
GUDID 40841716100664 ACIST MEDICAL SYSTEMS, INC.	ACIST RXi® System and Accessories	2019-04-15
GUDID 40841716100619 ACIST MEDICAL SYSTEMS, INC.	ACIST CVi® Angiographic Injection System	2019-04-15
GUDID 40841716100602 ACIST MEDICAL SYSTEMS, INC.	ACIST CVi® Angiographic Injection System	2019-04-15
GUDID 30841716101350 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2019-04-15
GUDID 30841716100629 ACIST MEDICAL SYSTEMS, INC.	ACIST CVi® Angiographic Injection System Control Panel	2019-04-15
GUDID 30841716100339 ACIST MEDICAL SYSTEMS, INC.	CPT2000 Automated Manifold Kit	2019-04-15
GUDID 30841716100261 ACIST MEDICAL SYSTEMS, INC.	B2000 Automated Manifold Kit	2019-04-15
GUDID 30841716100223 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2019-04-15
GUDID 30841716100124 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2019-04-15
GUDID 10841716100618 ACIST MEDICAL SYSTEMS, INC.	ACIST CVi® Angiographic Injection System Injector Head	2019-04-15
GUDID 10841716100601 ACIST MEDICAL SYSTEMS, INC.	ACIST CVi® Angiographic Injection System Injector Head	2019-04-15
GUDID 10841716100199 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2019-04-15
GUDID 30841716101930 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2019-04-10
GUDID 30841716101923 ACIST MEDICAL SYSTEMS, INC.	BT2000 Automated Manifold Kit	2019-04-10
GUDID 30841716101664 ACIST MEDICAL SYSTEMS, INC.	BT2000 Automated Manifold Kit	2019-04-10
GUDID 30841716100643 ACIST MEDICAL SYSTEMS, INC.	BT2000 Automated Manifold Kit	2019-04-10
GUDID 30841716100322 ACIST MEDICAL SYSTEMS, INC.	BT2000 Automated Manifold Kit	2019-04-10
GUDID 30841716100308 ACIST MEDICAL SYSTEMS, INC.	BT2000 Automated Manifold Kit	2019-04-10
GUDID 30841716100247 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2019-04-10
GUDID 30841716100230 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2019-04-10
GUDID 30841716100162 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2019-04-10
GUDID 30841716100148 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2019-04-10
GUDID 30841716100131 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2019-04-10
GUDID 30841716100094 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2019-04-10
GUDID 10841716101394 ACIST MEDICAL SYSTEMS, INC.	AngioTouch® Kit	2019-04-10
GUDID 30841716102180 ACIST MEDICAL SYSTEMS, INC.	RXi® Cable	2019-02-18
GUDID 40841716102101 ACIST MEDICAL SYSTEMS, INC.	ACIST HDi® HD IVUS System	2018-12-31
GUDID 40841716102057 ACIST MEDICAL SYSTEMS, INC.	ACIST HDi® HD IVUS System	2018-12-31
GUDID 30841716102074 ACIST MEDICAL SYSTEMS, INC.	RXi® Cable	2018-10-29
GUDID 30841716102067 ACIST MEDICAL SYSTEMS, INC.	RXi® Cable	2018-10-29
PMN K171646 | DXT ACIST MEDICAL SYSTEMS, INC.	ACIST CVi? Contrast Delivery System	2018-03-08
PMN K171646 | DXT ACIST MEDICAL SYSTEMS, INC.	ACIST CVi? BT2000 Manifold Kit	2018-03-08
PMN K171646 | DXT ACIST MEDICAL SYSTEMS, INC.	ACIST CVi? AngioTouch? Kit AT P65	2018-03-08
PMN K171646 | DXT ACIST MEDICAL SYSTEMS, INC.	ACIST CVi? AngioTouch? Kit AT P54	2018-03-08
PMN K171646 | DXT ACIST MEDICAL SYSTEMS, INC.	ACIST CVi? A2000 Syringe Kit	2018-03-08
PMN K171646 ACIST Medical Systems, Inc.	ACISTCVi® Contrast Delivery System	2018-02-16
PMN K173063 | OBJ ACIST MEDICAL SYSTEMS, INC.	ACIST Kodama? Intravascular Ultrasound Catheter	2017-10-30
PMN K173063 | OBJ ACIST MEDICAL SYSTEMS, INC.	ACIST HDi? System	2017-10-30
PMN K173063 | IYO ACIST MEDICAL SYSTEMS, INC.	ACIST Kodama? Intravascular Ultrasound Catheter	2017-10-30
PMN K173063 | IYO ACIST MEDICAL SYSTEMS, INC.	ACIST HDi? System	2017-10-30
PMN K173063 ACIST Medical Systems, Inc.	ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System	2017-10-23
PMN K172216 | DRQ ACIST MEDICAL SYSTEMS, INC.	ACIST RXi Mini System and Accessories	2017-09-21
PMN K172216 ACIST Medical Systems, Inc.	ACIST RXi Mini System	2017-08-18
OUG ACIST MEDICAL SYSTEMS, INC.	ACIST Connect	2016-08-15
PMN K984231 | DXT ACIST MEDICAL SYSTEMS, INC.	A2000 Multi-use Syringe Kit, A2000V Multi-use Syringe Kit, B/BT2000 Automated Manifold Kit	2014-08-04
PMN K052744 | DXT ACIST MEDICAL SYSTEMS, INC.	CPT2000 Automated Manifold Kit	2014-08-04
PMN K040298 | DXT ACIST MEDICAL SYSTEMS, INC.	AngioTouch Handcontroller Kits (Models ATP54, ATP65, ATR54, ATL65)	2014-08-04
PMN K132474 | OBI ACIST MEDICAL SYSTEMS, INC.	Rapid Exchange (RXi) System	2014-03-10
PMN K132474 | OBI ACIST MEDICAL SYSTEMS, INC.	Navvus Catheter	2014-03-10
PMN K132474 | DXO ACIST MEDICAL SYSTEMS, INC.	Rapid Exchange (RXi) System	2014-03-10
PMN K132474 | DXO ACIST MEDICAL SYSTEMS, INC.	Navvus Catheter	2014-03-10
PMN K093657 ACIST MEDICAL SYSTEMS, INC.	ADAGIO RETRACTING ECG LEAD WIRES	2010-01-15
PMN K063029 | JAK ACIST MEDICAL SYSTEMS, INC.	EmpowerCTA Injector System (Empower Sync Remote)	2008-07-10
PMN K063029 | IZQ ACIST MEDICAL SYSTEMS, INC.	EmpowerCTA Injector System (Empower Sync Remote)	2008-07-10
PMN K063029 | DSB ACIST MEDICAL SYSTEMS, INC.	EmpowerCTA Injector System (Empower Sync Remote)	2008-07-10
PMN K031571 | JAK ACIST MEDICAL SYSTEMS, INC.	EmpowerCTA/EmpowerCTA+	2008-07-10
PMN K031571 | IZQ ACIST MEDICAL SYSTEMS, INC.	EmpowerCTA/EmpowerCTA+	2008-07-10
PMN K011160 | JAK ACIST MEDICAL SYSTEMS, INC.	EmpowerCTA/EmpowerCTA+	2008-07-10
PMN K011160 | DSB ACIST MEDICAL SYSTEMS, INC.	EmpowerCTA/EmpowerCTA+	2008-07-10
PMN K052744 ACIST MEDICAL SYSTEMS, INC.	C2000 AUTOMATED MANIFOLD KIT	2005-12-16
PMN K040298 ACIST MEDICAL SYSTEMS, INC.	ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS	2004-03-15
PMN K012983 ACIST MEDICAL SYSTEMS, INC.	ACIST 4 FRENCH ANGIOGRAPHIC CATHETER	2002-03-13
PMN K991103 | DXT ACIST MEDICAL SYSTEMS, INC.	CVI INJECTION SYSTEM	2002-01-14
PMN K991103 | DXT ACIST MEDICAL SYSTEMS, INC.	CMS2000	2002-01-14
PMN K010390 | DXT ACIST MEDICAL SYSTEMS, INC.	E2000 VOYAGER	2002-01-14
PMN K010390 | DXT ACIST MEDICAL SYSTEMS, INC.	CVi	2002-01-14
PMN K010390 ACIST MEDICAL SYSTEMS, INC.	ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS	2001-03-09