# K222023: RayFlow

- Pathway: 510(k) (Traditional)
- Applicant: Hexacath
- Decided: Apr 6, 2023 after 269 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945904 (1995). 20 ancestors in all.
No later device cites it as a predicate yet.
2 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180959: Phenom 27 Catheter, Cathera, Inc. (2018) Summary page 4.
- K170544: Langston dual lumen catheter, Vascular Solutions, Inc. (2017) Summary page 5.

## Indications for use
The RayFlow catheter is intended to be used in adults (patients aged 22 years and older) for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the coronary vasculature. The RayFlow is not intended to be used in the neurovasculature

Source page: https://510kreport.com/device/K222023
Methodology: https://510kreport.com/methodology