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Twin-Pass OTW Catheter, Model 5201

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072618

by Vascular Solutions, Inc.

Identifiers

510(k) Number
K072618 FDA 510(k)
FDA Product Code
DQY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Twin-Pass OTW Catheter, Model 5201, is a dual-lumen, over-the-wire catheter classified under the nomenclature for vascular catheters. It is designed to facilitate the simultaneous placement of two guidewires, infusion of contrast media, or delivery of therapeutic agents within arterial vasculature, enabling selective access to distal vascular sites.

This sterile, single-use device supports 0.014-inch (0.36mm) guidewires and is intended for percutaneous procedures. Supplied as a ready-to-use catheter, it adheres to FDA 510(k) clearance under the product code DQY, with a traditional review pathway. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use.

Frequently asked questions

What is the Twin-Pass OTW Catheter used for?

The Twin-Pass OTW Catheter is designed for percutaneous procedures, allowing simultaneous placement of two guidewires, infusion of contrast media, or delivery of therapeutic agents within arterial vasculature to enable selective access to distal vascular sites.

What guidewire size is compatible with this catheter?

This catheter supports 0.014-inch (0.36mm) guidewires, making it suitable for procedures requiring precise guidewire navigation in arterial vasculature.

Is the Twin-Pass OTW Catheter reusable?

No, this is a sterile, single-use device that must not be reused to ensure patient safety and maintain device integrity.

How is the Twin-Pass OTW Catheter supplied?

The catheter is supplied as a ready-to-use device that has undergone FDA 510(k) clearance under product code DQY with a traditional review pathway.

What are the storage requirements for this catheter?

Storage and handling must comply with sterile medical device protocols to ensure the catheter's integrity prior to use, maintaining its sterility and functionality.

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: PDF Twin-Pass Dual Access Catheters - teleflex.com, TWIN-PASS OTW CATHETER, MODEL 5201 - Innolitics, Twin-Pass OTW Catheter - Vascular Solutions | FDA Reference

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) K072618 24 fields · synced Sep 19, 2026