# K253048: High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Maiwei Biotech Co., Ltd.
- Decided: Apr 16, 2026 after 206 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: 9 generations back to K934086 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211564: Sterile High-pressure Angiographic Syringes for Single-use, Shenzhen Boon Medical Supply Co., Ltd. (2021) Summary page 5.

## Indications for use
The high pressure syringe, pressure connecting tube, quick fill tube, spike and transfer tube are intended to connect with US legally marketed angiographic injectors for the injection of Contrast media or saline. They are for single use and provided sterile. For a complete list of compatible device models, accessories, and compatible injectors, refer to the device Instructions for Use.

Source page: https://510kreport.com/device/K253048
Methodology: https://510kreport.com/methodology