# K221470: Langston dual lumen catheter

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, LLC
- Decided: Jun 17, 2022 after 28 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: 2 generations back to K943739 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

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

## Indications for use
Each 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/K221470
Methodology: https://510kreport.com/methodology