Langston Dual Lumen Pressure Monitoring Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K050168

Identifiers

510(k) Number: K050168 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 cardiovascular device designed for pressure monitoring. It is a dual-lumen catheter intended for use in vascular access procedures.

This device is supplied non-sterile and is intended for single-use. It is used in clinical settings for hemodynamic monitoring and has received FDA 510(k) clearance under product code DQO.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K050168	Class II	Active

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Manufacturer

Manufacturer: Vascular Solutions, Inc.

Sources (1)

FDA 510(k) K050168 24 fields · synced Oct 6, 2026