ACIST CVi1 Contrast Delivery System

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Full name

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System

Trade Name

ACIST CVi Contrast Delivery System

Model / Reference

ACIST CVi Contrast Delivery System 110V/220V, 014657

Primary DI / UDI-DI

10841716102445

Basic UDI-DI

B-10841716102445

510(k) Number

K203004 ↗

FDA Product Code

DXT

EMDN Code

Z11039014 Multiple contrast agent injectors

Device Class

Class IIb EUDAMED

Class II 510(k)

Regulation

21 CFR Part 870.1650

EU market of registration

Netherlands

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

Manufacturer's product page: ACIST CVi®

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  Class IIb

  CE/MDD

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See all devices from ACIST Medical Systems, Inc. →

• What is the primary purpose of the ACIST CVi1 Contrast Delivery System in a clinical setting?

  The ACIST CVi1 Contrast Delivery System is designed specifically for precise, automated delivery of contrast media during coronary angiography. It enhances image clarity and procedural efficiency by ensuring consistent flow rates and volumes, which are critical for accurate visualization of coronary arteries during cardiac catheterization.

• Is the ACIST CVi1 Contrast Delivery System reusable or single-use, and what does this mean for my workflow?

  The ACIST CVi1 Contrast Delivery System is a reusable medical device, meaning it is intended to be used repeatedly after proper cleaning, calibration, and maintenance. This design allows for cost efficiency and reduces waste, though it requires adherence to manufacturer guidelines for sterilization and upkeep to ensure safety and performance consistency across procedures.

• What types of syringes are used with the ACIST CVi1 Contrast Delivery System, and are they included in the purchase?

  The ACIST CVi1 Contrast Delivery System operates with disposable syringes, which are not part of the reusable device itself. These syringes are designed to be compatible with the injector for contrast media delivery, ensuring a seamless workflow during coronary angiography procedures. You will need to source these syringes separately.

• What regulatory pathways has the ACIST CVi1 Contrast Delivery System followed, and what does this imply for its use?

  The ACIST CVi1 Contrast Delivery System has undergone FDA 510(k) clearance and complies with the EU Medical Device Directive (MDD), classified under EU category 870.1650 as a Class II device. This implies it has met stringent regulatory standards for safety and performance, ensuring it can be legally used in both U.S. and EU markets under the respective compliance frameworks. Proper training is required for setup, calibration, and maintenance to adhere to these regulatory requirements.

• Does the ACIST CVi1 Contrast Delivery System require any special training or maintenance to operate effectively?

  Yes, the ACIST CVi1 Contrast Delivery System requires proper training for setup, calibration, and maintenance to ensure accurate contrast injection and patient safety. This is because precise flow rates and volumes are critical for successful coronary angiography, and any deviation could compromise image quality or patient outcomes. Manufacturers typically provide training programs to ensure staff are competent in operating the device.