# K050873: Canalizer Hydrophilic Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: May 26, 2005 after 50 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 K863138 (1986). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955801: Radifocus Glidewire GT with Gold Coil,Glidewire Gold, Terumo Medical Corp. (1996) Summary page 1.
- K924202: Radifocus (R) (Catheter) Guide Wire, Terumo Medical Corp. (1992). Our reading of the summary gave K924204, FDA’s number for New Ultrasound Imaging System & Transducers (Tetra Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Terumo Radifocus Guidewire”.
- K863138: Terumo Radifocus Guide Wire, Terumo Medical Corp. (1986) Summary page 1.

## Most influential descendants
- K073672: Skater Biliary Catheter (2008), 0 descendants of its own

## Indications for use
The CanaliZer Hydrophilic Guide Wire is designed for use in the peripheral vasculature with medical devices requiring a 0.035" or 0.038" outer diameter guidewire. The CanaliZer is not intended for use in the coronary arteries.

Source page: https://510kreport.com/device/K050873
Methodology: https://510kreport.com/methodology