Acist Medical Systems, Inc.
Eden Prairie, MN, US
ACIST MEDICAL SYSTEMS, INC. appears in FDA device records in Eden Prairie, MN. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Acist Medical Systems, Inc. between 1999 and 2026. The busiest year on record is 2019, with 3. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 2 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2010 | 1 |
| 2014 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 2 |
| 2024 | 1 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery System | IZQ | Substantially Equivalent | |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable | DXT | Substantially Equivalent | |
| 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 | |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | DXO | Substantially Equivalent | |
| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | DXT | Substantially Equivalent | |
| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter | OBJ | Substantially Equivalent | |
| K190473 | ACIST RXi System and Navvus II Catheter | OBI | Substantially Equivalent | |
| 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 | |
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | OBJ | Substantially Equivalent | |
| K171646 | ACISTCVi® Contrast Delivery System | DXT | Substantially Equivalent | |
| K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | OBJ | Substantially Equivalent | |
| K172216 | ACIST RXi Mini System | DRQ | Substantially Equivalent | |
| K132474 | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER | DXO | Substantially Equivalent | |
| K093657 | ADAGIO RETRACTING ECG LEAD WIRES | DSA | Substantially Equivalent | |
| K052744 | C2000 AUTOMATED MANIFOLD KIT | DXT | Substantially Equivalent | |
| K040298 | ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS | DXT | Substantially Equivalent | |
| K020892 | ACIST GENTOO CONTRAST INJECTION SYSTEM | DXT | Substantially Equivalent | |
| K021015 | ACIST PLUS 4 ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K012983 | ACIST 4 FRENCH ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K010390 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS | DXT | Substantially Equivalent | |
| K991103 | MODIFICATION TO ACIST CL 100H | DXT | Substantially Equivalent | |
| K000013 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000 | DXT | Substantially Equivalent | |
| K993774 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH | DXT | Substantially Equivalent | |
| K984058 | ACIST INJECTOR SYSTEM, MODEL CL100 H | IZQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2134243 | 3001726808 | ACIST MEDICAL SYSTEMS, INC. | 7905 FULLER ROAD, EDEN PRAIRIE, MN 55344 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DRQAmplifier And Signal Conditioner, Transducer Signal
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- DQOCatheter, Intravascular, Diagnostic
- OBICatheter, Pressure Monitoring, Cardiac
- OBJCatheter, Ultrasound, Intravascular
- DXTInjector And Syringe, Angiographic
- IZQInjector, Contrast Medium, Automatic
- DSBPlethysmograph, Impedance
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- JAKSystem, X-Ray, Tomography, Computed
- DXOTransducer, Pressure, Catheter Tip
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1161-2021 | 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 peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System. | 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 have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence. | Class I | Terminated | |
| Z-0744-2016 | 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 BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST). To be used for the controlled infusion of radiopaque contrast media for angiographic procedures | Reports related to ingress of air into the manifold. | Class II | Terminated | |
| Z-1145-2013 | 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 Manifold Kit is necessary in order to proceed w | Class II | Terminated | |
| Z-1872-2009 | 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 injection manifold, a pressure transducer cartridge, a check valve, tubing (low, high and peristaltic pump), and a saline spike. This kit is designed for exclusive use with the ACIST CMS2000, E2000 Voyager and CVi models of Angiographic Contrast Delivery Systems. This kit is for single use. | 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. | Terminated | ||
| Z-0643-2009 | 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 interventional cardiology, radiology, and vascular surgical procedures. The ACIST injection system supplies radiopaque contrast media to a catheter at a user-determined variable flow rate and volume which can be instantaneously and continuously varied. Manufactured by: ACIST Medical Systems, Inc., 7905 Fuller Road, Eden Prairie, MN 55344, USA. The ACIST CVi injection system is able to synchronize with certain X-ray imaging systems from Siemens, Toshiba, GE and Philips. Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures. | 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. | Terminated | ||
| Z-2406-2008 | 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 controlled infusion of radiopaque contrast media for angiographic procedures. | 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. | Terminated | ||
| Z-0359-2008 | 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 multiple use A20000 syringe kit is comprised of a terminally sterilized syringe barrel and a contrast spike assembly) | Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture. | Terminated | ||
| Z-1002-04 | 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. | Terminated | ||
| Z-0064-04 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain