# K170915: TXM Hydrophilic Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Texasmedical Technologies, Inc.
- Decided: Nov 21, 2017 after 238 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: 2 generations back to K000011 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133155: Hydrophilic Coated Guidewire, Lake Region Medical (2014) Summary page 4.

## Indications for use
To facilitate the placement of devices during diagnostic or interventional procedures.

Source page: https://510kreport.com/device/K170915
Methodology: https://510kreport.com/methodology