# K241109: Single-use Sterile High-pressure Angiographic Syringes and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Boon Medical Supply Co., Ltd.
- Decided: Aug 22, 2024 after 122 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 4.

## Indications for use
Single-use Sterile High-pressure Angiographic Syringe and Accessories are intended for the injection of contrast media or saline, they shall be used with U.S. legally marketed angiographic injectors.

Source page: https://510kreport.com/device/K241109
Methodology: https://510kreport.com/methodology