# K053265: Micrus Guide Wire, Watusi 0.014

- Pathway: 510(k) (Traditional)
- Applicant: Micrus Endovascular Corporation
- Decided: Apr 28, 2006 after 157 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971254 (1997). 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)
- K971254: Transend EX Platinum Guidewire, Boston Scientific Corp (1997) Summary page 1.

## Recalls of this device
- Sep 8, 2006 · Not classified · Z-1542-06: During use, the introducer may cause the guide wire''s coating to strip off and may result in loose material which could break free and enter the blood stream.

## Indications for use
Micrus Watusi guide wire is intended for general intravascular use, including the neuro and peripheral vasculature. The Watusi guide wire is not intended for use in the coronary arteries. The guide wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. A torque device (pin vise) is included with the guide wire to facilitate directional manipulation of the guide wire. An introducer device is included to introduce the guide wire into the catheter or hemostatic valve, and can also be used to shape the flexible tip of the guide wire, as desired.

Source page: https://510kreport.com/device/K053265
Methodology: https://510kreport.com/methodology