Radifocus Glidewire Advantage Track
by Ashitaka Factory of Terumo Coporation
510(k) K163004
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163004 | Date30 Jan 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Radifocus Glidewire Advantage Track is a peripheral guidewire designed to direct a catheter to the desired anatomical location, including use as a lower limb guide wire during diagnostic or interventional procedures. It features a hybrid wire design for enhanced torque control and support, aiding navigation of complex peripheral vascular challenges.
This device is supplied by the manufacturer Ashitaka Factory of Terumo Corporation and has received FDA 510(k) clearance under K163004 with product code DQX. It is intended for use in peripheral vascular interventions, including ilio-femoro-popliteal and below-the-knee treatments, and supports catheter placement from sheath insertion to target lesion crossing.
Questions
AI-generated answers, 1 Oct 2026
What is the Radifocus Glidewire Advantage Track used for?
It is designed to direct a catheter to the desired anatomical location, including use as a lower limb guide wire during diagnostic or interventional peripheral vascular procedures, supporting navigation from sheath insertion to target lesion crossing in ilio-femoro-popliteal and below-the-knee treatments.
How is the Radifocus Glidewire Advantage Track supplied and is it sterile?
The device is supplied by the manufacturer Ashitaka Factory of Terumo Corporation; however, the provided data does not specify sterility or single-use/reuse status, so no conclusion can be drawn about its supply format or sterility from the given information.
What regulatory clearance does the Radifocus Glidewire Advantage Track have?
It has received FDA 510(k) clearance under K163004 with product code DQX, as stated in the device data, indicating it was found substantially equivalent to a legally marketed predicate device.