đź“‹ FDA Reference
Wingman Extendable Tip Support Catheter
Summary: The Wingman Extendable Tip Support Catheter is a specialized device used to facilitate the placement of guidewires in complex vascular procedures. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K120178 ↗
Decision Date ?
February 8, 2012
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Wingman Extendable Tip Support Catheter, manufactured by Reflow Medical, was cleared through the FDA 510(k) pathway on February 8, 2012. It is classified as a Class 2 device under product code DQY.
What It Is
The Wingman Extendable Tip Support Catheter is a medical device designed to assist in the navigation and placement of guidewires within the vascular system. Its extendable tip provides enhanced support and maneuverability, making it particularly useful in challenging vascular anatomy. This device is often utilized in procedures requiring precise guidewire placement, such as those involving tortuous or occluded vessels.
FDA-Cleared Indications
- Facilitation of guidewire placement during percutaneous vascular procedures.
- Support and navigation of guidewires through challenging vascular anatomy.
Clinical Applications
- Guidewire placement during percutaneous vascular interventions.
- Navigation through tortuous or otherwise difficult vascular pathways.
- Guidewire support during endovascular treatment of vascular occlusions when consistent with the device labeling.
- Use in image-guided vascular procedures performed by trained clinicians.
Practical Considerations
- The catheter is available in different sizes and configurations; the appropriate size depends on the access route, target vessel, guidewire, and planned intervention.
- It is used with compatible guidewires and requires careful advancement, retraction, and manipulation of the extendable tip.
- The device is intended for use under fluoroscopic or other appropriate vascular imaging guidance by trained clinicians.
- MRI safety and conditional-use information must be confirmed in the current manufacturer labeling; do not assume the device is MR safe.
- General contraindications and risks of percutaneous vascular catheterization apply, including bleeding, vascular injury, dissection, perforation, thrombosis, infection, and device-related complications.
Procedures that use this device
Frequently Asked Questions
What is the Wingman Extendable Tip Support Catheter used for?
It is used to facilitate the placement of guidewires in complex vascular procedures, especially in challenging anatomical situations.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating guidewire placement in vascular procedures, particularly in complex or difficult-to-navigate vessels.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.