# K032920: The Coeur Injector Adaptor/Pressure Jacket, Model C859-6003

- Pathway: 510(k) (Traditional)
- Applicant: Coeur Medical
- Decided: Dec 16, 2003 after 85 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K070798: Adapters for CT, Angiographic, and/or Mri Power Injectors (2007), 2 descendants of its own
- K170431: CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip (2017), 0 descendants of its own
- K133600: Coeur, Inc. Frontload for Optivantage Power Injector (2014), 0 descendants of its own

## Indications for use
The Coeur Injector Adaptor / Pressure Jacket is intended to be installed on Liebel-Flarsheim Angiomat 6000 and Angiomat Illumena Contrast Delivery Systems to allow the injectors to be used with the Coeur 150mL A-Series (Angiographic and CT) Syringes (Catalog Numbers: C853-6150 and C853-6159).

Source page: https://510kreport.com/device/K032920
Methodology: https://510kreport.com/methodology