# K173052: Heraeus TMW Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Medical Components, LLC
- Decided: Oct 20, 2017 after 22 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913353 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152709: HI-Torque Balance, Abbott Vascular (2015) Summary page 4.

## Indications for use
The Heraeus TMW Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices during Percutaneous Transluminal Angioplasty (PTA) and/or Percutaneous Transluminal Coronary Angioplasty (PTCA).

Source page: https://510kreport.com/device/K173052
Methodology: https://510kreport.com/methodology