# K051395: Langston Dual Lumen Pressure Monitoring Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Jun 24, 2005 after 28 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 6 (5 Class I)
- 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.
8 later devices descend from it; 3 cite it directly.
3 of 10 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 Catheters: 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
- 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

## Recalls of this device
- Aug 31, 2020 · Class I · Z-0111-2021: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
- Aug 31, 2020 · Class I · Z-0112-2021: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
- Aug 31, 2020 · Class I · Z-0110-2021: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
- Mar 16, 2020 · Class I · Z-1747-2020: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
- May 27, 2014 · Class I · Z-1981-2014: The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece fro
- Sep 2, 2010 · Not classified · Z-2608-2010: Investigation of a recent Device Experience Report has made us aware of a potential problem with our 6F Langston dual lumen pigtail catheter (Model 5540) with the following lot numbers: 548110, 548227

## Indications for use
The Vascular Solutions Langston TM 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 transvalvular, intravascular and intraventricular pressure gradients.

Source page: https://510kreport.com/device/K051395
Methodology: https://510kreport.com/methodology