# K170544: Langston dual lumen catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Nov 17, 2017 after 266 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: 3 generations back to K810412 (1981). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061565: Langston Dual Lumen Catheter, Vascular Solutions, Inc. (2006) Summary page 4.
- K051395: Langston Dual Lumen Pressure Monitoring Catheter, Vascular Solutions, Inc. (2005) Summary page 4.

## Most influential descendants
- K222023: RayFlow (2023), 0 descendants of its own

## Indications for use
The Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients.

Source page: https://510kreport.com/device/K170544
Methodology: https://510kreport.com/methodology