# K984231: Angiographic Contrast Management System, Model Part a and Part B

- Pathway: 510(k) (Traditional)
- Applicant: Invasatec
- Decided: May 31, 2000 after 553 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K903493 (1991). 4 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963982: Acist Angiographic Injector, Invasatec (1997). Our OCR of the scanned summary read K963882, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Acist Injection System”.
- K961794: Fluid Administration Set - Contrast Manager, Merit Medical Systems, Inc. (1996) Summary page 1.
- K903493: Namic Contrast Savings Delivery System, North American Instrument Corp. (1991) Summary page 1.

## Most influential descendants
- K052744: C2000 Automated Manifold Kit (2005), 14 descendants of its own
- K131478: Contrast Conservation System (2013), 13 descendants of its own
- K140425: Contrast Modulation System (2014), 12 descendants of its own
- K150485: AVERT Contrast Modulation System (2015), 10 descendants of its own
- K151300: AVERT Contrast Modulation System (2015), 8 descendants of its own

## Recalls of this device
- Dec 21, 2015 · Class II · Z-0744-2016: Reports related to ingress of air into the manifold.
- Oct 3, 2007 · Not classified · Z-0359-2008: Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture.
- May 19, 2004 · Not classified · Z-1002-04: Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.
- Oct 2, 2003 · Not classified · Z-0064-04: 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 al

## Indications for use
The Acist ™ CMS-2000 Angiographic Injection System with Contrast Management is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Source page: https://510kreport.com/device/K984231
Methodology: https://510kreport.com/methodology