# K113454: 14 Wire Standard, 14 Wire LS

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: Feb 24, 2012 after 95 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: 1 generation back to K964611 (1997). 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)
- K971254: Transend EX Platinum Guidewire, Boston Scientific Corp (1997) Summary page 1.
- K964611: Transend Guidewire, Boston Scientific Corp (1997) Summary page 1.

## Indications for use
The 14 Wire Hydrophilic Guidewire is indicated far general use to aid in the selective placement of catheters inthe peripheral and cerebral intravascular during diagnostic and/or therapeutic procedures. The device is not intended for vasculature use in the coronary arteries. The Guidewire Torque Device is intended to facilitate guidewire manipulation during interventional procedures. The Guidewire Introducer is intended to facilitate guidewire insertion into a catheter hub or through a hemostasis valve.

Source page: https://510kreport.com/device/K113454
Methodology: https://510kreport.com/methodology