# K023591: Ultra High Pressure Injector Lines

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Jun 18, 2003 after 236 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: 2 generations back to K911884 (1994). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822100: High Pressure Contrast Injection Line, Namic (1982) Summary page 1.
- K963749: High Pressure Injection Lines, Maxxim Medical (1996) Summary page 1.

## Most influential descendants
- K071196: Disposable High Pressure Injection Lines with and Without Rotating Adapters (2007), 2 descendants of its own
- K140356: Summed High Pressure Line (2015), 0 descendants of its own
- K131770: Pressure Connecting Tube (2014), 0 descendants of its own

## Indications for use
The DeRoyal Industries, Inc., Ultra High Pressure Injector Lines are indicated for use during coronary angiography procedures as a connecting line for the injection of radio-opaque dye or saline.

Source page: https://510kreport.com/device/K023591
Methodology: https://510kreport.com/methodology