# K061565: Langston Dual Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Aug 2, 2006 after 58 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K810412 (1981). 6 ancestors in all.
6 later devices descend from it; 3 cite it directly.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041909: Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP), Vascular Solutions, Inc. (2004) Summary page 1.
- K050168: Langston Dual Lumen Pressure Monitoring Catheter, Vascular Solutions, Inc. (2005) Summary page 1.
- K051395: Langston Dual Lumen Pressure Monitoring Catheter, Vascular Solutions, Inc. (2005) Summary page 1.

## Most influential descendants
- K062627: Innerchange Micro-Introducer Catheter, Models 7900 Through 7905 (2007), 2 descendants of its own
- K170544: Langston dual lumen catheter (2017), 1 descendant of its own
- K073585: Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905 (2008), 1 descendant of its own
- K222023: RayFlow (2023), 0 descendants of its own
- K081846: Grebset Micro-Introducer Kit, Models 7950, 7951 (2009), 0 descendants of its own

## Recalls of this device
- Aug 31, 2020 · Class I · Z-0113-2021: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
- Jun 9, 2011 · Not classified · Z-2770-2011: Vascular Solutions, Inc investigation of a recent Device Experience Report has made them aware of a potential problem with their 7F Langston dual lumen pigtail catheter (Model 5515) with lot number 54

## Indications for use
The LangstonTM 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/K061565
Methodology: https://510kreport.com/methodology