# 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

- Pathway: 510(k) (Traditional)
- Applicant: Coeur, Inc.
- Decided: Aug 18, 2017 after 186 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
Longest line of descent: 5 generations back to K934086 (1995). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051799: Disposable CT/MR Syringes for Nemoto Injectors, Coeur, Inc. (2005) Summary page 4.
- K960965: Front Load Injector Turret Model 859-0001/200 ML Front Load Syringe Model 853-0211, Coeur Laboratories, Inc. (1996) Summary page 4.
- K070798: Adapters for CT, Angiographic, and/or Mri Power Injectors, Coeur, Inc. (2007) Summary page 4.
- K161471: MR Syringe Dual Pack for Solaris Injectors, Coeur, Inc. (2016) Summary page 4.
- K063090: Medrad Stellant CT Injector System with XDS Accessory, Medrad, Inc. (2007) Summary page 4.

## Indications for use
For use with the Medrad® Stellant® CT Injection System equipped with the appropriate Coeur Fascia and Ram Tip for the injection of contrast media or saline to the vascular system for diagnostic purposes.

Source page: https://510kreport.com/device/K170431
Methodology: https://510kreport.com/methodology