Radifocus Glidewire Advantage
510(k) K063372
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063372 | Date19 Jan 2007 | 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- Withdrawn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 is a guidewire classified under the DQX product code, designed for use in peripheral vascular interventions. It is intended to assist in the placement and navigation of catheters through blood vessels, including complex and tortuous anatomy such as ilio-femoral and below-the-knee vessels. Its hydrophilic coating enhances maneuverability and crossability, facilitating access to target lesions during diagnostic or interventional procedures. The device is engineered to support sheath placement and guidewire navigation in peripheral interventions, excluding use in the heart or central circulatory system.
This guidewire is supplied as a single-use, non-sterile device and is intended for use in controlled clinical settings such as catheterization labs or interventional radiology suites. It is not MRI-safe and must be handled with sterile technique during procedures. The device is authorized under FDA 510K clearance (K063372) and is distributed by Terumo Medical Corp. Proper storage and handling are essential to maintain its performance and sterility before use.
Other devices from Terumo Medical Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the Radifocus Glidewire Advantage used for?
The Radifocus Glidewire Advantage is designed specifically for peripheral vascular interventions. It assists clinicians in guiding catheters through challenging blood vessel pathways, such as ilio-femoral and below-the-knee vessels, which are often tortuous or complex. Its hydrophilic coating improves maneuverability, making it easier to navigate to target lesions during diagnostic or interventional procedures. This guidewire is not intended for use in the heart or central circulatory system.
Is the Radifocus Glidewire Advantage sterile and single-use?
The Radifocus Glidewire Advantage is supplied as a single-use device and is non-sterile. It is intended for use in controlled clinical settings where sterile technique can be applied during procedures, such as catheterization labs or interventional radiology suites. Sterilization must be performed by the user prior to use in accordance with standard clinical practices.
Can this guidewire be used with MRI equipment?
No, the Radifocus Glidewire Advantage is not MRI-safe. It should not be used in or near MRI equipment, as this could pose risks to both the patient and the device. Always verify compatibility with imaging modalities before use.
How should the Radifocus Glidewire Advantage be stored?
Proper storage is essential to maintain the performance and integrity of the Radifocus Glidewire Advantage. It should be stored in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Follow manufacturer guidelines for packaging and handling to ensure the device remains in optimal condition for use.
What regulatory clearance does the Radifocus Glidewire Advantage hold?
The Radifocus Glidewire Advantage holds FDA 510K clearance under the product code DQX, with a clearance number of K063372. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and has been authorized for use in peripheral vascular interventions as described.