AciST CL 100H Modification

• • Terminated Z-0643-2009 FDA Unclassified (pre-2012) ·initiated 10 Nov 2008

  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-1002-04 FDA Unclassified (pre-2012) ·initiated 19 May 2004

  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 FDA Unclassified (pre-2012) ·initiated 2 Oct 2003

  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.

Full name

Modification to Acist Cl 100H

510(k) Number

K991103 ↗

FDA product code

DXT

FDA applicant

Acist Medical Systems

Device class

Class II

Regulation

21 CFR Part 870.1650

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

• Triple Transducer Cable

  Class I

  CE/MDR

• ACIST CVi Contrast Delivery System

  Class IIb

  CE/MDD

• ACIST VeraPro HiFi 165 018804

  Class II

  FDA 510(k) K252638 Active Cleared 13 May 2026 GUDID on market

• ACIST VeraPro FLX 165 018806

  Class II

  FDA 510(k) K252638 Active Cleared 13 May 2026 GUDID on market

• ACIST VeraPro S100 Multi-Use Syringe 018808

  Class II

  FDA 510(k) K252638 Active Cleared 13 May 2026 GUDID on market

• ACIST VeraPro S100 LV1 Low-Viscosity Syringe 018811

  Class II

  FDA 510(k) K252638 Active Cleared 13 May 2026 GUDID on market

See all devices from ACIST Medical Systems, Inc. →

• What types of procedures is the AciST CL 100H Modification designed to support in a catheterization lab?

  The AciST CL 100H Modification is specifically designed for use in cardiovascular procedures, particularly those requiring angiographic imaging. It functions as an electro-mechanical contrast injector, delivering precise contrast media during coronary or peripheral angiograms to enhance visualization of blood vessels.

• Is the AciST CL 100H Modification intended for single-use or reusable applications?

  This modification is intended for single-use with disposable components, including a two-port syringe and manifold. The electro-mechanical base unit is not disposable but is paired with these single-use accessories for each procedure.

• How is the device regulated, and what does that mean for its use in clinical settings?

  The AciST CL 100H Modification received FDA 510(k) clearance (K991103) as a substantially equivalent modification to the original CL 100H system. This means it has been reviewed and deemed comparable to a previously cleared device, ensuring compliance with FDA standards for safety and effectiveness in angiographic applications.

• Can this device be used in an MRI environment, and if not, why?

  No, the AciST CL 100H Modification is not MRI-safe due to its electro-mechanical components, which could pose risks in magnetic resonance imaging environments. It is explicitly designed for use in catheterization labs where MRI compatibility is not required.

• What storage and handling precautions should be taken for the disposable components of this device?

  The disposable components (such as the syringe and manifold) follow standard sterile medical device protocols for catheter lab use. They should be stored in a clean, dry environment, protected from contamination, and handled using aseptic techniques to maintain sterility before use.