# K133600: Coeur, Inc. Frontload for Optivantage Power Injector

- Pathway: 510(k) (Traditional)
- Applicant: Coeur, Inc.
- Decided: Apr 30, 2014 after 156 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: 4 generations back to K912944 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070798: Adapters for CT, Angiographic, and/or Mri Power Injectors, Coeur, Inc. (2007)
- K993728: Medrad Envision CT Injector System, Medrad, Inc. (1999) Summary page 1.
- K063503: Optivantage DH Injector System with Enhanced Communication, Mallinckrodt Inc., Liebel-Flarsheim Business (2007) Summary page 1.

## Indications for use
For use in adapting Liebel-Elarsheim Optivantage DH Injectors for use with Coeur Front load Syringes

Source page: https://510kreport.com/device/K133600
Methodology: https://510kreport.com/methodology