# K150902: 330psi Extension Y-Line with Dual Check Valve

- Pathway: 510(k) (Traditional)
- Applicant: Coeur, Inc.
- Decided: Oct 22, 2015 after 202 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: 1 generation back to K120892 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120892: Disposable 330PSI Extension Lines, Coeur, Inc. (2013) Summary page 4.

## Indications for use
The 330psi Extension Y-Line with Dual Check Valve is to be used as an interface between an Angiographic, CT, or MR Syringe 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/K150902
Methodology: https://510kreport.com/methodology