# K140356: Summed High Pressure Line

- Pathway: 510(k) (Traditional)
- Applicant: Sunny Medical Device (Shenzhen) Co., Ltd.
- Decided: Mar 20, 2015 after 401 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K911884 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071196: Disposable High Pressure Injection Lines with and Without Rotating Adapters, Coeur, Inc. (2007) Summary page 4.
- K023591: Ultra High Pressure Injector Lines, Deroyal Industries, Inc. (2003) Summary page 4.

## Indications for use
The SunmedTM High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.

Source page: https://510kreport.com/device/K140356
Methodology: https://510kreport.com/methodology