# K040298: Acist Antiographic Injection System Contrast Management Disposable Kits

- Pathway: 510(k) (Special)
- Applicant: Acist Medical Systems, Inc.
- Decided: Mar 15, 2004 after 35 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) B2000, Automated Manifold Kit (w/o Transducer): named in the summary without a submission number
- (no number) BT2000, Automated Manifold Kit (w/Transducer): named in the summary without a submission number
- (no number) H1000, AngioTouch Hand Controller: named in the summary without a submission number
- (no number) EH2000, AngioTouch Hand Controller: named in the summary without a submission number
- (no number) H1000P, AngioTouch Hand Controller: named in the summary without a submission number
- (no number) EH2000P, AngioTouch Hand Controller: named in the summary without a submission number
- (no number) H1000IJ, AngioTouch Hand Controller: named in the summary without a submission number
- (no number) H1000J, AngioTouch Hand Controller: named in the summary without a submission number

## Recalls of this device
- Mar 15, 2013 · Class II · Z-1145-2013: 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 ai
- May 11, 2009 · Not classified · Z-1872-2009: 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 dur
- Jun 6, 2008 · Not classified · Z-2406-2008: 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.

## Indications for use
The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Source page: https://510kreport.com/device/K040298
Methodology: https://510kreport.com/methodology