Data / Medical devices / United States / Acist Medical Systems, Inc.
Acist Medical Systems, Inc.: FDA-registered device maker in Eden Prairie, MN, United States, 22 510(k) clearances
Acist Medical Systems, Inc. is registered with the FDA (registration 2134243) in Eden Prairie, MN, United States. It lists 9 device types. The FDA files 22 510(k) clearances under its listings, the newest dated August 3, 2026. 9 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2134243
- FEI number
- 3001726808
- Address
- 7905 Fuller Road, Eden Prairie, MN, United States, 55344
- Owner or operator
- ACIST MEDICAL SYSTEMS, INC. (9028115)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- January 14, 2002
- Registered through
- 2027
- Brand names listed
- A1000V Syringe Kit, A2000 Multi-use Syringe Kit, A2000V Multi-use Syringe Kit, B/BT2000 Automated Manifold Kit, ACIST CVi®1 Contrast Delivery System, ACIST CVi® A2000 Syringe Kit, ACIST CVi® AngioTouch® Kit AT P54, ACIST CVi® AngioTouch® Kit AT P65, ACIST CVi® BT2000 Manifold Kit, ACIST CVi® Contrast Delivery System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Catheter, Pressure Monitoring, Cardiac | OBI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Injector And Syringe, Angiographic | DXT | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Injector, Contrast Medium, Automatic | IZQ | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Plethysmograph, Impedance | DSB | 2 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Transducer, Pressure, Catheter Tip | DXO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 3, 2026 | K262115 | VueJect® Ultrasound Enhancing Agent Delivery System | IZQ | Substantially Equivalent | ACIST Medical Systems, Inc. | accessdata.fda.gov |
| May 13, 2026 | K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable | DXT | Substantially Equivalent | Acist Medical Systems, Inc. | accessdata.fda.gov |
| May 13, 2026 | 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 | Substantially Equivalent | Acist Medical Systems, Inc. | accessdata.fda.gov |
| July 17, 2024 | K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | DXO | Substantially Equivalent | Acist Medical Systems, Inc. | accessdata.fda.gov |
| December 17, 2020 | K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | DXT | Substantially Equivalent | Acist Medical Systems, Inc. | accessdata.fda.gov |
| March 20, 2020 | K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter | OBJ | Substantially Equivalent | Acist Medical Systems, Inc. | accessdata.fda.gov |
| September 13, 2019 | K190473 | ACIST RXi System and Navvus II Catheter | OBI | Substantially Equivalent | Acist Medical Systems, Inc. | accessdata.fda.gov |
| July 18, 2019 | K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit | DXT | Substantially Equivalent | Acist Medical Systems, Inc. | accessdata.fda.gov |
| June 27, 2019 | K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | OBJ | Substantially Equivalent | Acist Medical Systems, Inc. | accessdata.fda.gov |
| February 16, 2018 | K171646 | ACISTCVi® Contrast Delivery System | DXT | Substantially Equivalent | Acist Medical Systems, Inc. | accessdata.fda.gov |
| October 23, 2017 | K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | OBJ | Substantially Equivalent | Acist Medical Systems, Inc. | accessdata.fda.gov |
| August 18, 2017 | K172216 | ACIST RXi Mini System | DRQ | Substantially Equivalent | Acist Medical Systems, Inc. | accessdata.fda.gov |
| January 22, 2016 | K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set | IZQ | Substantially Equivalent | Bracco Injeneering | accessdata.fda.gov |
| January 30, 2014 | K132474 | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER | DXO | Substantially Equivalent | Acist Medical Systems | accessdata.fda.gov |
| June 13, 2007 | K071378 | MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES | JAK | Substantially Equivalent | E-Z-Em, Inc. | accessdata.fda.gov |
| April 13, 2007 | K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | IZQ | Substantially Equivalent | E-Z-Em, Inc. | accessdata.fda.gov |
| December 16, 2005 | K052744 | C2000 AUTOMATED MANIFOLD KIT | DXT | Substantially Equivalent | Acist Medical Systems, Inc. | accessdata.fda.gov |
| March 15, 2004 | K040298 | ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS | DXT | Substantially Equivalent | Acist Medical Systems, Inc. | accessdata.fda.gov |
| June 19, 2003 | K031571 | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 | IZQ | Substantially Equivalent | E-Z-Em, Inc. | accessdata.fda.gov |
| May 16, 2001 | K011160 | E-Z EM PERCUPUMP 2001 CT INJECTOR | JAK | Substantially Equivalent | E-Z-Em, Inc. | accessdata.fda.gov |
| May 31, 2000 | K991103 | MODIFICATION TO ACIST CL 100H | DXT | Substantially Equivalent | Acist Medical Systems | accessdata.fda.gov |
| May 31, 2000 | K984231 | ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B | DXT | Substantially Equivalent | Invasatec | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 22, 2021 | 87254 | Class I | Terminated | ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and p | Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There hav | accessdata.fda.gov |
| December 21, 2015 | 72913 | Class II | Terminated | ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The B | Reports related to ingress of air into the manifold. | accessdata.fda.gov |
| March 15, 2013 | 64840 | Class II | Terminated | ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures. | ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifol | accessdata.fda.gov |
| May 11, 2009 | 52199 | Not yet classified | Terminated | ACIST Automated Manifold Kit, REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, Manufacturer; ACIST LMedical Systems Inc, 7605 Fuller Road, Eden Prairie, MN.55344. The automated manifold kit is comprised of an i | ACIST Medical Systems initiated a recall due to an increase in the incidence of field reports related to a bulge on the side and/or leaks in the bond of the 2.5 high-pressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the ACIST BT2000 Automated Manifold Kit. | accessdata.fda.gov |
| November 10, 2008 | 50501 | Not yet classified | Terminated | ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Part Number 700318-002. The ACIST injection system is an angiographic injection system used in interventiona | Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an injection scenario that may result in multiple injections of contract media when one injection was intended. | accessdata.fda.gov |
| June 6, 2008 | 49075 | Not yet classified | Terminated | ACIST" BRACCO, AT P54 AngioTouch Kit, SKU # 014644, Sterile EO Manufacturer; ACTB Medical Systems, Inc. 7905 Fuller Road, Eden Prairie, MN 55344, Made in Mexico. Catalogue No: 800608-013 Intended to be used for the contr | Some of the sterile package seals of AT P54 AngioTouch Kit were breached. Breached package seals could compromise product sterility, which could potentially lead to patient infection. | accessdata.fda.gov |
| October 3, 2007 | 45465 | Not yet classified | Terminated | ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical Systems, Inc., 7450 Flying Cloud Drive, Suite 150, Eden Prairie, MN 55344, USA. Catalogue No: 800061-003. (The mul | Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture. | accessdata.fda.gov |
| May 19, 2004 | 29159 | Not yet classified | Terminated | AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System. | Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile. | accessdata.fda.gov |
| October 2, 2003 | 27388 | Not yet classified | Terminated | ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units) | Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Pressure, Catheter Tip
- All makers of Injector And Syringe, Angiographic
- All makers of Amplifier And Signal Conditioner, Transducer Signal
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Catheter, Ultrasound, Intravascular
Updated August 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.