đź“‹ FDA Reference
Wingman Extendable Tip Support Catheter
Summary: The Wingman Extendable Tip Support Catheter is a device used to facilitate the placement of guidewires in vascular procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K141547 ↗
Decision Date ?
September 30, 2014
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Wingman Extendable Tip Support Catheter by Reflow Medical was cleared through the FDA 510(k) pathway on September 30, 2014. It is a Class 2 medical device.
What It Is
The Wingman Extendable Tip Support Catheter is a specialized catheter designed to assist in the navigation and placement of guidewires through challenging vascular anatomy. It features an extendable tip that provides enhanced support and maneuverability, making it easier to access difficult-to-reach areas within the vasculature. This device is particularly useful in procedures that require precise guidewire placement.
FDA-Cleared Indications
- Facilitation of guidewire placement during vascular procedures.
- Use in percutaneous vascular interventions when additional catheter support is needed for guidewire navigation.
Clinical Applications
- Supporting guidewire placement during percutaneous vascular interventions.
- Helping navigate tortuous or otherwise challenging vascular anatomy.
- Providing catheter support during endovascular procedures in the arterial or venous vasculature.
Practical Considerations
- Available sizes and configurations should be selected according to the target vessel, access route, guidewire, and planned intervention.
- Use is generally performed under fluoroscopic or other intravascular imaging guidance by trained clinicians.
- Operators should understand the extendable-tip mechanism before use and avoid excessive force, which may contribute to vessel injury or device damage.
- Compatibility with the selected guidewire, introducer sheath, and other endovascular equipment should be confirmed before the procedure.
- MRI safety and conditions should be verified in the current manufacturer labeling; the FDA record alone does not establish that the device is MR Safe or MR Conditional.
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 challenging vascular anatomy during endovascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating guidewire placement in vascular procedures, particularly in complex vascular anatomy.
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.