# K965214: Coeur Front Load Injector Retrofit Kit (C859-0002)

- Pathway: 510(k) (Traditional)
- Applicant: Coeur Laboratories, Inc.
- Decided: Mar 28, 1997 after 88 days
- Product code: DTX (Gas Control Unit, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Coeur Front Load Injector Turret: named in the summary without a submission number
- (no number) Coeur Front Load Syringe: named in the summary without a submission number
- (no number) Medrad MCT and MCT Plus Injector with Front Load Syringe: named in the summary without a submission number

## Most influential descendants
- K051799: Disposable CT/MR Syringes for Nemoto Injectors (2005), 18 descendants of its own
- K072696: Ant Angiographic Syringes, Model (S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 (2008), 15 descendants of its own
- K151960: Sterile High-pressure Angiographic Syringes for Single-use (2016), 8 descendants of its own
- K192657: Sterile High-pressure Angiographic Syringes for Single-use (2020), 4 descendants of its own
- K211564: Sterile High-pressure Angiographic Syringes for Single-use (2021), 2 descendants of its own

## Indications for use
The Coeur Front Load Injector Retrofit Kit is intended to be used with Medrad MCT and MCT Plus Injectors to hold the Coeur 200 mL Front Load Syringe in place in front of the Injector Ram during the injection of contrast media into the vascular system for diagnostic purposes.

Source page: https://510kreport.com/device/K965214
Methodology: https://510kreport.com/methodology