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Langston Dual Lumen Pressure Monitoring Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K051395

by Vascular Solutions, Inc.

Identifiers

510(k) Number
K051395 FDA 510(k)
FDA Product Code
DQO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1200 FDA 510(k)
Regulation Number
870.1200 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Langston Dual Lumen Pressure Monitoring Catheter is a dual lumen catheter with a coaxial design that provides accurate and stable pressure measurements. It enables simultaneous pressure measurements across the aortic valve to help clinicians compute the pressure gradient and effective orifice area.

This catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. It is supplied as a single-use device and requires appropriate storage conditions. The device has received FDA 510(k) clearance with product code DQO and is manufactured by Vascular Solutions, Inc.

Frequently asked questions

What is the Langston Dual Lumen Pressure Monitoring Catheter used for?

The Langston Dual Lumen Pressure Monitoring Catheter is designed for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites, enabling clinicians to compute the pressure gradient and effective orifice area across the aortic valve.

Is the Langston Dual Lumen Pressure Monitoring Catheter reusable or single-use?

The Langston Dual Lumen Pressure Monitoring Catheter is supplied as a single-use device and should not be reused. It requires appropriate storage conditions to maintain its integrity and functionality.

What regulatory approvals does the Langston Dual Lumen Pressure Monitoring Catheter have?

The Langston Dual Lumen Pressure Monitoring Catheter has received FDA 510(k) clearance with product code DQO. It is manufactured by Vascular Solutions, Inc. and was cleared on June 24, 2005.

What is the design and function of the Langston Dual Lumen Pressure Monitoring Catheter?

The Langston Dual Lumen Pressure Monitoring Catheter features a dual lumen coaxial design that provides accurate and stable pressure measurements. This design allows for simultaneous pressure measurements across the aortic valve to help clinicians compute the pressure gradient and effective orifice area.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Langston® Dual Lumen Catheter | US | Teleflex, PDF Langston Dual Lumen Catheter - teleflex.com, PDF KCy53L3' - Food and Drug Administration, Langston Dual Lumen Pressure Monitoring Catheter

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vascular Solutions, Inc.

Sources (1)

  • FDA 510(k) K051395 24 fields · synced Oct 6, 2026