# K050168: Langston Dual Lumen Pressure Monitoring Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: May 18, 2005 after 112 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 K943739 (1994). 1 ancestor in all.
15 later devices descend from it; 2 cite it directly.
4 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943739: Softouch Diagnostic Intravascular Catheter, Mallinckrodt Medical (1994) Summary page 1.
- (no number) Langston Dual Lumen Pigtail Catheter: named in the summary without a submission number
- (no number) Cordis Dual Lumen Pressure Monitoring Catheter: named in the summary without a submission number

## Most influential descendants
- K063723: Impella Recover LP 2.5 Percutaneous Cardiac Support System (2008), 7 descendants of its own
- K061565: Langston Dual Lumen Catheter (2006), 6 descendants of its own
- K083111: Impella 5.0 Catheter Family (2009), 3 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K062627: Innerchange Micro-Introducer Catheter, Models 7900 Through 7905 (2007), 2 descendants of its own

## Indications for use
The Vascular Solutions Langston Dual Lumen Pressure Monitoring 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 transvatvular, intravascular and intraventricular pressure gradients.

Source page: https://510kreport.com/device/K050168
Methodology: https://510kreport.com/methodology