BEUDAMED
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    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.

    FDA Enforcement
    Class II ·Terminated·Acist Medical Systems·April 24, 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.

    FDA Recall
    Terminated ·Acist Medical Systems·Product code DXT·March 15, 2013

    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.

    FDA Recall
    Terminated ·Acist Medical Systems·Product code DXT·May 11, 2009

    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

    FDA Enforcement
    Class II ·Terminated·Acist Medical Systems·February 10, 2016

    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.

    FDA Recall
    Terminated ·Acist Medical Systems·Product code DXT·November 10, 2008

    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

    FDA Recall
    Terminated ·Acist Medical Systems·Product code DXT·December 21, 2015

    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.

    FDA Recall
    Terminated ·Acist Medical Systems·Product code OBJ·January 22, 2021

    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)

    FDA Recall
    Terminated ·Acist Medical Systems·Product code DXT·October 3, 2007

    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.

    FDA Enforcement
    Class I ·Terminated·Acist Medical Systems·March 10, 2021

    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.

    FDA Recall
    Terminated ·Acist Medical Systems·Product code DXT·June 6, 2008

    AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.

    FDA Recall
    Terminated ·Acist Medical Systems·Product code DXT·May 19, 2004

    ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units)

    FDA Recall
    Terminated ·Acist Medical Systems·Product code DXT·October 2, 2003

    Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.

    FDA Recall
    Terminated ·Invivo Corporation·Product code MWI·October 15, 2012