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ACIST Angiographic Injection System Contrast Management Disposable Kits

by ACIST Medical Systems, Inc.

510(k) K040298

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK040298 Date15 Mar 2004ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1145-2013 FDA Class II initiated 15 Mar 2013

    ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed w

    • Terminated Z-1872-2009 FDA Unclassified (pre-2012) initiated 11 May 2009

    ACIST Medical Systems initiated a recall due to an increase in the incidence of field reports related to a bulge on the side and/or leaks in the bond of the 2.5 high-pressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the ACIST BT2000 Automated Manifold Kit.

    • Terminated Z-2406-2008 FDA Unclassified (pre-2012) initiated 6 Jun 2008

    Some of the sterile package seals of AT P54 AngioTouch Kit were breached. Breached package seals could compromise product sterility, which could potentially lead to patient infection.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Acist Antiographic Injection System Contrast Management Disposable Kits
510(k) Number
FDA Product Code
DXT
Device Class
Class II
Regulation
21 CFR Part 870.1650
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ACIST Angiographic Injection System Contrast Management Disposable Kits are designed as Injector and Syringe, Angiographic (per FDA nomenclature). These kits facilitate the precise delivery of radiopaque contrast media during angiographic procedures, ensuring controlled infusion for enhanced imaging accuracy in cardiovascular diagnostics.

The system is supplied as single-use disposable kits and is intended for use in clinical settings requiring sterile contrast administration. Authorized under FDA 510K clearance (K040298), the kits comply with 21 CFR Part 870.1650 regulations. No MRI safety or reusable components are specified. Multiple reference codes (e.g., 1000208624, 3002808086) denote variations in kit configurations, though exact sizes or storage conditions are not detailed in the data.

From the manufacturer

ACIST Medical Systems provides innovative contrast injector & IVUS catheter diagnostic technologies to visualize, assess & improve patient treatment.

Source: acist.com

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