# K242143: Angiography Injector

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Int Medical Instruments Co., Ltd.
- Decided: Dec 23, 2024 after 154 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 K980580 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163084: Merit Coronary Control Syringe, Merit Medical Systems, Inc. (2017) Summary page 5.

## Indications for use
The Angiography Injector is intended to aspirate and inject contrast media in the interventional procedure. It can also be used to inject fluids into, or withdraw fluids from the body.

Source page: https://510kreport.com/device/K242143
Methodology: https://510kreport.com/methodology