Company · US
Acist Medical Systems
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2026. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (3 in 12 months)
9recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXT | Injector And Syringe, Angiographic | 20 |
| OBJ | Catheter, Ultrasound, Intravascular | 4 |
| DQO | Catheter, Intravascular, Diagnostic | 2 |
| DXO | Transducer, Pressure, Catheter Tip | 2 |
| IZQ | Injector, Contrast Medium, Automatic | 2 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 |
| OBI | Catheter, Pressure Monitoring, Cardiac | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 3, 2026 | K262115 | VueJect® Ultrasound Enhancing Agent Delivery System ACIST Medical Systems, Inc. | IZQ |
| May 13, 2026 | K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Ca Acist Medical Systems, Inc. | DXT |
| May 13, 2026 | K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Ma Acist Medical Systems, Inc. | DXT |
| Jul 17, 2024 | K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ Acist Medical Systems, Inc. | DXO |
| Dec 17, 2020 | K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System Acist Medical Systems, Inc. | DXT |
| Mar 20, 2020 | K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter Acist Medical Systems, Inc. | OBJ |
| Sep 13, 2019 | K190473 | ACIST RXi System and Navvus II Catheter Acist Medical Systems, Inc. | OBI |
| Jul 18, 2019 | K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, An Acist Medical Systems, Inc. | DXT |
| Jun 27, 2019 | K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System Acist Medical Systems, Inc. | OBJ |
| Feb 16, 2018 | K171646 | ACISTCVi® Contrast Delivery System Acist Medical Systems, Inc. | DXT |
| Oct 23, 2017 | K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System Acist Medical Systems, Inc. | OBJ |
| Aug 18, 2017 | K172216 | ACIST RXi Mini System Acist Medical Systems, Inc. | DRQ |
| Jan 30, 2014 | K132474 | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER Acist Medical Systems | DXO |
| Jan 15, 2010 | K093657 | ADAGIO RETRACTING ECG LEAD WIRES Acist Medical Systems, Inc. | DSA |
| Dec 16, 2005 | K052744 | C2000 AUTOMATED MANIFOLD KIT Acist Medical Systems, Inc. | DXT |
| Mar 15, 2004 | K040298 | ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS Acist Medical Systems, Inc. | DXT |
| Jan 27, 2003 | K020892 | ACIST GENTOO CONTRAST INJECTION SYSTEM Acist Medical Systems | DXT |
| Apr 26, 2002 | K021015 | ACIST PLUS 4 ANGIOGRAPHIC CATHETER Acist Medical Systems | DQO |
| Mar 13, 2002 | K012983 | ACIST 4 FRENCH ANGIOGRAPHIC CATHETER Acist Medical Systems, Inc. | DQO |
| Mar 9, 2001 | K010390 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS Acist Medical Systems, Inc. | DXT |
| May 31, 2000 | K991103 | MODIFICATION TO ACIST CL 100H Acist Medical Systems | DXT |
| Mar 28, 2000 | K000013 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000 Acist Medical Systems | DXT |
| Dec 7, 1999 | K993774 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH Acist Medical Systems | DXT |
| Feb 11, 1999 | K984058 | ACIST INJECTOR SYSTEM, MODEL CL100 H Acist Medical Systems | IZQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2021 | Acist Medical Systems 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 examina Terminated |
OBJ | K193183 |
| Feb 2, 2016 | Acist Medical Systems 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 Terminated |
DXT | K052744 K984231 |
| Apr 18, 2013 | Acist Medical Systems 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. Terminated |
DXT | K040298 |
| Aug 30, 2009 | Acist Medical Systems 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 ki Terminated |
DXT | K040298 |
| Jan 8, 2009 | Acist Medical Systems 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 Terminated |
DXT | K010390 K991103 |
| Sep 23, 2008 | Acist Medical Systems 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 t Terminated |
DXT | K040298 |
| Dec 8, 2007 | Acist Medical Systems 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: Terminated |
DXT | K984231 |
| Jul 20, 2004 | Acist Medical Systems AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System. Terminated |
DXT | K984231 K991103 |
| Oct 24, 2003 | Acist Medical Systems ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units) Terminated |
DXT | K984231 K991103 |