đź“‹ FDA Reference
wingman extendable tip support catheter
Reflow Medical
Summary: The Wingman Extendable Tip Support Catheter is a device used to facilitate the placement of guidewires in the peripheral vasculature. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K101479 ↗
Decision Date
August 11, 2010
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Wingman Extendable Tip Support Catheter was cleared via the FDA 510(k) pathway on August 11, 2010. Manufactured by Reflow Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Wingman Extendable Tip Support Catheter is a specialized catheter designed to assist in the navigation and placement of guidewires within the peripheral vasculature. It features an extendable tip that can be adjusted to provide additional support and stability during procedures. This design helps in crossing difficult lesions and navigating tortuous anatomy, enhancing procedural success.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery, particularly in procedures involving the placement of stents or other interventions in the peripheral arteries or veins. It is valuable in settings where precise guidewire placement is critical, such as in patients with complex vascular anatomies or chronic total occlusions. The device is suitable for use in both hospital and outpatient settings.
Indications for Use
The Wingman Extendable Tip Support Catheter is indicated for use in facilitating the placement and support of guidewires in the peripheral vasculature. It is particularly useful in patients with challenging vascular anatomies requiring enhanced guidewire support.
Practical Considerations
The catheter is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard guidewires and can be used in conjunction with other interventional devices. Clinicians should be familiar with its extendable tip mechanism to optimize its use during procedures.
Frequently Asked Questions
What is the Wingman Extendable Tip Support Catheter used for?
It is used to facilitate the placement of guidewires in the peripheral vasculature, especially in challenging anatomical situations.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for facilitating guidewire placement in the peripheral vasculature, particularly in complex vascular anatomies.
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.