# K070798: Adapters for CT, Angiographic, and/or Mri Power Injectors

- Pathway: 510(k) (Traditional)
- Applicant: Coeur, Inc.
- Decided: Oct 4, 2007 after 195 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: 2 generations back to K934086 (1995). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965214: Coeur Front Load Injector Retrofit Kit (C859-0002), Coeur Laboratories, Inc. (1997) Summary page 1.
- K960965: Front Load Injector Turret Model 859-0001/200 ML Front Load Syringe Model 853-0211, Coeur Laboratories, Inc. (1996) Summary page 1.
- K912944: CT 8000 Digital Injection System, Mallinckrodt Group, Inc. (1992) Summary page 1.
- K993728: Medrad Envision CT Injector System, Medrad, Inc. (1999) Summary page 1.
- K032920: The Coeur Injector Adaptor/Pressure Jacket, Model C859-6003, Coeur Medical (2003) Summary page 1.
- K924116: Medrad MCT, MCT Plus Injector/Medrad Front Load, Medrad, Inc. (1993) Summary page 1.

## Most influential descendants
- 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
for use in adapting CT and/or Angiographic power injectors for use with Coeur Syringes

Source page: https://510kreport.com/device/K070798
Methodology: https://510kreport.com/methodology