# K124007: Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire, X-Pedion Hydrophilic Guidewire, Mirage HY

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc. D/B/A: Ev3, Inc.
- Decided: Mar 7, 2013 after 71 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 K982543 (1998). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982543: Silverstreak Hydrophilic Guidewire, Micro Therapeutics, Inc. (1998) Summary page 1.
- K993257: .010 Silverspeed Hydropophilic Guidewire, .014 Silversped Hydrophilic Guidewire, .016 Silverspeed Hydrophilic Guidewi, Micro Therapeutics, Inc. (1999) Summary page 1.
- K010497: Silverspeed Hydrophilic Guidewire, Models 103-0601-300 and 103-0602-300, Micro Therapeutics, Inc. (2001) Summary page 1.
- K001454: Silverspeed Hydrophilic Guidewire (0.014 Diameter, 145CM Length, Support) Silverspeed Hydrophilic Guidewire (0.014 D, Micro Therapeutics, Inc. (2000) Summary page 1.
- K002212: Mirage Hydrophilic Guidewire, Model 103-0608, Micro Therapeutics, Inc. (2000) Summary page 1.

## Most influential descendants
- K193548: Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire (2020), 1 descendant of its own
- K201690: Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire (2020), 0 descendants of its own

## Indications for use
The SilverSpeed™, Mirage™, X-celerator™ Exchange and X-pedion™ Hydrophilic Guidewires are 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/K124007
Methodology: https://510kreport.com/methodology