C2000 AUTOMATED MANIFOLD KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACISTCVi® Contrast Delivery System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST RXi System and Navvus II Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADAGIO RETRACTING ECG LEAD WIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST RXi Mini System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST 4 FRENCH ANGIOGRAPHIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

A2000 SYRINGE KIT

Basic UDI-DI

EU MDR · Eu Md Class 2a ·ACIST Medical Systems, Inc.·6 devices

NEXO

Basic UDI-DI

EU MDR · Eu Md Class 1 ·ACIST Medical Systems, Inc.·1 device

ACIST Europe BV

Authorized representative

🇳🇱 Netherlands·4 Manufacturers·14 Devices

ACIST Europe BV

Importer

🇳🇱 Netherlands·4 Manufacturers

MPS Medical Product Service GmbH

Authorized representative

🇩🇪 Germany·35 Manufacturers·1959 Devices

Siemens Healthcare NV/SA

Importer

🇧🇪 Belgium·24 Manufacturers