# K041909: Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP)

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Sep 23, 2004 after 70 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: 1 generation back to K810412 (1981). 3 ancestors in all.
7 later devices descend from it; 1 cites it directly.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914141: Cordis Dual Lumen Pressure Monitoring Catheter, Cordis Corp. (1991) Summary page 2.
- K943739: Softouch Diagnostic Intravascular Catheter, Mallinckrodt Medical (1994) Summary page 1.
- K810412: Usci Cardiovascular Catheter, C.R. Bard, Inc. (1981) Summary page 2.

## Most influential descendants
- K061565: Langston Dual Lumen Catheter (2006), 6 descendants of its own
- 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

## Indications for use
The Vascular Solutions Langston TM Dual Lumen Pigtail 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/K041909
Methodology: https://510kreport.com/methodology