# K162088: Ecomed Disposable Angiographic Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Ecomed Solutions, LLC
- Decided: Jan 27, 2017 after 183 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: 7 generations back to K934086 (1995). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082439: Disposable Angiographic Syringe, Model (S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT, Shandong Weigao Medical Polymer Co., Ltd. (2009) Summary page 4.

## Indications for use
The product is a family of Angiographic Syringes for the injection of contrast media and saline. The syringe is for single use with US legally marketed angiographic injectors.

Source page: https://510kreport.com/device/K162088
Methodology: https://510kreport.com/methodology