# K163084: Merit Coronary Control Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jun 15, 2017 after 224 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: 3 generations back to K980580 (1998). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113198: Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 ML, Navilyst Medical, Inc. (2011) Summary page 4.
- K070936: Welmed Hypodermic Syringe, Welmed, Inc. (2007) Summary page 4.

## Most influential descendants
- K242143: Angiography Injector (2024), 0 descendants of its own

## Indications for use
The Merit Coronary Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media. The syringe can also be used to inject fluids into, or withdraw fluids from, the body.

Source page: https://510kreport.com/device/K163084
Methodology: https://510kreport.com/methodology