ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
Acist Medical Systems, Inc.
ACIST MEDICAL SYSTEMS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2134243 | 3001726808 | ACIST MEDICAL SYSTEMS, INC. | 1 | Y | 2026-01-01 | 7905 FULLER ROAD EDEN PRAIRIE MN US 55344 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 52798 | 1840460361 | K991103 | MODIFICATION TO ACIST CL 100H | DXT | 2000-05-31 |
| 52798 | 1358450926 | K984231 | ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B | DXT | 2000-05-31 |
| 52798 | 1583779667 | K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable | DXT | 2026-05-13 |
| 52798 | 1445417599 | K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) | DXT | 2026-05-13 |
| 52798 | 1835371284 | K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | DXO | 2024-07-17 |
| 52798 | 1001698103 | K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | DXT | 2020-12-17 |
| 52798 | 1180739219 | K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter | OBJ | 2020-03-20 |
| 52798 | 1474675456 | K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | OBJ | 2019-06-27 |
| 52798 | 2040362159 | K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit | DXT | 2019-07-18 |
| 52798 | 2046703280 | K190473 | ACIST RXi System and Navvus II Catheter | OBI | 2019-09-13 |
| 52798 | 1774530835 | K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | OBJ | 2017-10-23 |
| 52798 | 2017741563 | K172216 | ACIST RXi Mini System | DRQ | 2017-08-18 |
| 52798 | 1315154453 | K171646 | ACISTCVi® Contrast Delivery System | DXT | 2018-02-16 |
| 52798 | 1068922905 | K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set | IZQ | 2016-01-22 |
| 52798 | 1114655743 | K132474 | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER | DXO | 2014-01-30 |
| 52798 | 1961410948 | K071378 | MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES | JAK | 2007-06-13 |
| 52798 | 1814534919 | K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | IZQ | 2007-04-13 |
| 52798 | 1005095100 | K052744 | C2000 AUTOMATED MANIFOLD KIT | DXT | 2005-12-16 |
| 52798 | 2019105519 | K040298 | ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS | DXT | 2004-03-15 |
| 52798 | 1014189007 | K031571 | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 | IZQ | 2003-06-19 |
| 52798 | 1167649499 | K011160 | E-Z EM PERCUPUMP 2001 CT INJECTOR | JAK | 2001-05-16 |
| 52798 | 1413770572 | K010390 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS | DXT | 2001-03-09 |
| 52798 | 1187150950 | ||||
| 52798 | 1570934619 | ||||
| 52798 | 1812574291 |
Product Codes Associated With Registrations#
PMN#
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
ACIST Medical Systems, Inc.
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
ACIST Medical Systems, Inc.
ACIST RXi System And Navvus II Catheter
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
ACIST Medical Systems, Inc.
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
ACIST Medical Systems, Inc.
ACISTCVi® Contrast Delivery System
ACIST Medical Systems, Inc.
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
ACIST Medical Systems, Inc.
ACIST RXi Mini System
ACIST Medical Systems, Inc.
CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
ACIST MEDICAL SYSTEMS
ADAGIO RETRACTING ECG LEAD WIRES
ACIST MEDICAL SYSTEMS, INC.
C2000 AUTOMATED MANIFOLD KIT
ACIST MEDICAL SYSTEMS, INC.
ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
ACIST MEDICAL SYSTEMS, INC.
ACIST GENTOO CONTRAST INJECTION SYSTEM
ACIST MEDICAL SYSTEMS
ACIST PLUS 4 ANGIOGRAPHIC CATHETER
ACIST MEDICAL SYSTEMS
ACIST 4 FRENCH ANGIOGRAPHIC CATHETER
ACIST MEDICAL SYSTEMS, INC.
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
ACIST MEDICAL SYSTEMS, INC.
MODIFICATION TO ACIST CL 100H
ACIST MEDICAL SYSTEMS
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
ACIST MEDICAL SYSTEMS
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
ACIST MEDICAL SYSTEMS
ACIST INJECTOR SYSTEM, MODEL CL100 H
ACIST MEDICAL SYSTEMS
GUDID#
ACIST VeraPro AMT Auto-Manifold and Transducer - Auto-Manifold and Transducer
2026-05-26
ACIST VeraPro S100 LV1 Low-Viscosity Syringe - Single-use 100mL contrast reservoir and tubing with contrast spike for use with low viscosity contrast 1-15cP
2026-05-26
ACIST VeraPro S100 Multi-Use Syringe - 100mL contrast reservoir and tubing with contrast spike and clamp with disinfecting caps. Must be discarded after 5 patient cases.
2026-05-26
ACIST VeraPro FLX 165 - AngioTouch Hand Controller
2026-05-26
ACIST VeraPro HiFi 165 - AngioTouch Hand Controller
2026-05-26
ACIST HDi™ Cart - 017991
2026-03-04
CT Exprès Day Set III HP - 640460
2025-12-09
CT Exprès Bottle Spike A - 640458
2025-12-09
ACIST CVi® Contrast Delivery System - CVi Injector p/n 800620-024Contents: CVi Injector Head (Siemens), Control Panel, & Power Supply
2018-06-13
ACIST CVi® Contrast Delivery System - CVi Injector p/n 800620-023Contents: CVi Injector Head, Control Panel, & Power Supply
2018-06-13
CVi® Cable - CVi Medex Spacelabs cable, p/n 300501-001
2018-06-05
ACIST CVi®1 Contrast Delivery System - CVi1 Injector p/n 801091-002Contents: CVi Injector Head (Siemens), Bed Mount, & Power Supply
2019-10-17
ACIST CVi® Contrast Delivery System - CVi Injector p/n 801091-001Contents: CVi Injector Head, Bed Mount, & Power Supply
2019-10-17
ACIST CVi®1 Contrast Delivery System Injector Head - CVi1 Injector (Siemens), p/n 700708-011
2019-10-17
ACIST CVi®1 Contrast Delivery System Injector Head - CVi1 Injector, p/n 700706-011
2019-10-17
A2000 Multi-use Syringe Kit - A2000 Multi-use Syringe Kit, p/n 701669-002Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp with disinfecting caps
2018-11-30
ACIST CVi® Contrast Delivery System Power Supply - CVi Power Supply p/n 701340-003
2018-06-13
ACIST CVi® Contrast Delivery System Control Panel - ACIST CVi® Contrast Delivery System Control Panel, p/n 701557-002
2018-06-13
ACIST CVi® Contrast Delivery System Injector Head - CVi Injector (Siemens), p/n 700708-010
2018-06-13
ACIST CVi® Contrast Delivery System Injector Head - CVi Injector, p/n 700706-010
2018-06-13
Single-use Syringe Kit - Model A1000V, p/n 701259-012Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp
2020-11-06
A1000 Single Use Syringe Kit - A1000 Single Use Syringe Kit, p/n 701669-009Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp.
2020-11-06
A2000 Multi-use Syringe Kit - A2000 Multi-use Syringe Kit, p/n 701669-008Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp with disinfecting caps
2020-11-06
A1000V Single Use Syringe Kit - A1000V Single Use Syringe KitKit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp.
2024-05-28
Single-use Syringe Kit - Model A1000V, p/n 701259-007Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp
2019-10-16
A1000 Single Use Syringe Kit - A1000 Single Use Syringe Kit, p/n 801060-003Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp.
2019-10-09
AngioTouch® Kit - Model AT P65, p/n 701677-001Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
2018-06-06
AngioTouch® Kit - Model AT P54, p/n 701675-001Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
2018-06-06
BT2000 Automated Manifold Kit - Model BT2000 p/n 701671-001Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe, transducer
2018-06-06
A2000 Multi-use Syringe Kit - A2000 Multi-use Syringe Kit, p/n 701669-001Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp with disinfecting caps
2018-06-06
BT2000 Automated Manifold Kit - Model BT2000Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe, transducer
2020-11-06
CT Exprès Patient Set - 640457
2025-08-15
ACIST Kodama® Coronary Imaging Catheter - Kodama Catheter,Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag
2025-08-14
ACIST RXi® System with dPR - RXi System with dPR, US (p/n: 800981-010 )
2025-01-20
ACIST RXi® Console with dPR - RXi Console with dPR, US (p/n: 800939-010 )
2025-01-20
ACIST Navvus®II Catheter - Navvus II Catheter, p/n 701711-003
2025-01-20
ACIST HDi® HD IVUS System - HDi System OverpackContents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply
2024-11-13
ACIST HDi® Power Supply - HDi Power Supply
2024-11-13
ACIST HDi® System Console - HDi System Console
2024-11-13
ACIST HDi® Power Supply - HDi Power Supply
2024-11-13