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Heraeus TMW Guidewire

FDA 510(k)

Class II (US FDA 510(k))

510(k) K173052

by Heraeus Medical Components Llc

Identifiers

510(k) Number
K173052 FDA 510(k)
FDA Product Code
DQX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1330 FDA 510(k)
Regulation Number
870.1330 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Heraeus TMW Guidewire is a steerable, disposable, bi-metal core guidewire used to facilitate catheter placement during PTA/PTCA. It features a Triton Nitinol distal core, stainless steel proximal core, hydrophilic coating, and a 3 cm radiopaque distal tip.

The device is supplied sterile and intended for single-use. It has received FDA 510(k) clearance under K173052 and is classified under product code DQX with cardiovascular advisory committee review.

Frequently asked questions

What is the Heraeus TMW Guidewire used for?

The Heraeus TMW Guidewire is used to facilitate catheter placement during percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA) procedures, providing steerability to navigate vascular anatomy.

Is the Heraeus TMW Guidewire sterile and for single-use only?

Yes, the device is supplied sterile and is intended for single-use only, as indicated in its description, to prevent cross-contamination and ensure patient safety during vascular access procedures.

What materials and features does the Heraeus TMW Guidewire have?

It features a Triton Nitinol distal core for flexibility and shape retention, a stainless steel proximal core for pushability, a hydrophilic coating to reduce friction, and a 3 cm radiopaque distal tip for enhanced visibility under fluoroscopy.

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: Heraeus TMW Guidewire (K173052) — FDA 510 (k) | Innolitics, Heraeus TMW Guidewire by Heraeus Medical Components, LLC | FDA 510(k ..., PDF Microsoft Word - Updated 510(k) Summary 10Sep17

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Heraeus Medical Components Llc
FDA Applicant
Heraeus Medical Components, LLC

Sources (1)

  • FDA 510(k) K173052 24 fields · synced Sep 25, 2026