# K182289: Sterile High-pressure Angiographic Syringes for Single-use

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Baoan Medical Supplies Co., Ltd.
- Decided: Oct 10, 2018 after 48 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)
- K151960: Sterile High-pressure Angiographic Syringes for Single-use, Shenzhen Baoan Medical Supplies Co., Ltd. (2016) Summary page 5.

## Indications for use
Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an US legally marketed angiographic injectors.

Source page: https://510kreport.com/device/K182289
Methodology: https://510kreport.com/methodology