# K120892: Disposable 330PSI Extension Lines

- Pathway: 510(k) (Traditional)
- Applicant: Coeur, Inc.
- Decided: Jun 10, 2013 after 444 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K242212: Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (2024), 0 descendants of its own
- K150902: 330psi Extension Y-Line with Dual Check Valve (2015), 0 descendants of its own

## Indications for use
To be used as an interface between (an) Angiographic, CT, or MR Syringe(s) and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.

Source page: https://510kreport.com/device/K120892
Methodology: https://510kreport.com/methodology