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TechDevice Guidewire

FDA 510(k)

Class II (US FDA 510(k))

510(k) K053028

by Techdevice Corporation

Identifiers

510(k) Number
K053028 FDA 510(k)
FDA Product Code
OCY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TechDevice Guidewire is an endoscopic guidewire used to facilitate placement and exchange of catheters and other instruments in the peripheral vasculature. It consists of a stainless steel core wire with a stainless steel or platinum coil. This device is not indicated for neuro or cardiac use.

The TechDevice Guidewire is supplied as a single-use device and is not MRI safe. It is regulated under FDA 510(k) clearance with the product code OCY and regulation number 876.1500. The device is manufactured by TechDevice Corporation and is classified as a Class II medical device.

Frequently asked questions

What is the TechDevice Guidewire used for?

The TechDevice Guidewire is an endoscopic guidewire designed to facilitate placement and exchange of catheters and other instruments in the peripheral vasculature. It is not indicated for neuro or cardiac use.

Is the TechDevice Guidewire single-use or reusable?

The TechDevice Guidewire is supplied as a single-use device and is not MRI safe. It should not be reused on multiple patients as this could compromise safety and effectiveness.

What is the regulatory classification of the TechDevice Guidewire?

The TechDevice Guidewire is regulated under FDA 510(k) clearance with the product code OCY and regulation number 876.1500. It is classified as a Class II medical device and manufactured by TechDevice Corporation.

What materials are used in the TechDevice Guidewire?

The TechDevice Guidewire consists of a stainless steel core wire with either a stainless steel or platinum coil. These materials provide the necessary strength and flexibility for endoscopic procedures in the peripheral vasculature.

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: TECHDEVICE GUIDEWIRE (K053251) — FDA 510(k) | Innolitics, TECHDEVICE GUIDEWIRE (K053028) — FDA 510(k) | Innolitics, PDF TechDevice Corporation 510(k) Premarket Notification (Traditional ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Techdevice Corporation

Sources (1)

  • FDA 510(k) K053028 24 fields · synced Sep 26, 2026