# K063372: Radifocus Glidewire Advantage

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Jan 19, 2007 after 72 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). 1 ancestor in all.
7 later devices descend from it; 5 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863138: Terumo Radifocus Guide Wire, Terumo Medical Corp. (1986) Summary page 1.

## Most influential descendants
- K213315: CROSSLEAD Peripheral Guide Wire (2022), 1 descendant of its own
- K122590: Radifocus Glidewire Advantage, Radifocus Glidewire Advantage (2013), 1 descendant of its own
- K113162: Slidewiretm (Trademark Pending) (2012), 1 descendant of its own
- K261281: CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 (2026), 0 descendants of its own
- K193653: Hydrophilic Coating Guide Wire (2020), 0 descendants of its own

## Indications for use
The Radifocus® Glidewire® Advantage is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures.

Source page: https://510kreport.com/device/K063372
Methodology: https://510kreport.com/methodology