# K201690: Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Jul 21, 2020 after 29 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: 3 generations back to K982543 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193548: Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2020) Summary page 4.

## Indications for use
The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

Source page: https://510kreport.com/device/K201690
Methodology: https://510kreport.com/methodology