# K152740: Radifocus Glidewire

- Pathway: 510(k) (Traditional)
- Applicant: Ashitaka Factory of Terumo Corp.
- Decided: Nov 16, 2015 after 54 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.
8 later devices descend from it; 5 cite it directly.
0 of 10 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 5.

## Most influential descendants
- K201081: AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter (2020), 3 descendants of its own
- K223918: AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub (2023), 2 descendants of its own
- K233853: LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub (2024), 1 descendant of its own
- K253146: Hyperdrive 35 Guidewire (2026), 0 descendants of its own
- K261281: CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 (2026), 0 descendants of its own

## Indications for use
The Glidewire is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

Source page: https://510kreport.com/device/K152740
Methodology: https://510kreport.com/methodology