# K093681: Meridian Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Ev3 Neurovascular
- Decided: Jan 26, 2010 after 60 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 K993257 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993257: .010 Silverspeed Hydropophilic Guidewire, .014 Silversped Hydrophilic Guidewire, .016 Silverspeed Hydrophilic Guidewi, Micro Therapeutics, Inc. (1999) Summary page 1.

## Indications for use
The Meridian 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/K093681
Methodology: https://510kreport.com/methodology