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wingman 18 crossing catheter
Reflow Medical
Summary: The Wingman 18 Crossing Catheter is a device used to facilitate the crossing of vascular lesions. It is typically used by interventional radiologists and cardiologists in procedures involving venous stents.
FDA Clearance Information
Pathway
510K
Number
K160848 ↗
Decision Date
July 14, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Wingman 18 Crossing Catheter was cleared through the FDA's 510(k) pathway on July 14, 2016. Manufactured by Reflow Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Wingman 18 Crossing Catheter is a specialized catheter designed to assist in crossing challenging vascular lesions. It features a unique tip that can be manipulated to navigate through occlusions in blood vessels. This device is particularly useful in peripheral vascular interventions, providing clinicians with enhanced control and precision during procedures.
Clinical Applications
This catheter is commonly used in interventional radiology and cardiology settings, particularly during procedures involving the placement of venous stents. It is ideal for patients with peripheral artery disease or chronic total occlusions where standard guidewires may struggle. The device is used in hospitals and specialized vascular centers, often on patients requiring revascularization of occluded vessels.
Indications for Use
The Wingman 18 Crossing Catheter is indicated for use in patients with vascular lesions that are difficult to cross with standard guidewires. It is particularly useful in cases of chronic total occlusions, where its design aids in navigating through tight or blocked vessels.
Practical Considerations
The Wingman 18 Crossing Catheter is typically compatible with standard guidewire systems and is available in various sizes to accommodate different vessel diameters. Clinicians should be familiar with its unique tip design and manipulation technique to maximize its effectiveness during procedures.
Frequently Asked Questions
What is the Wingman 18 Crossing Catheter used for?
It is used to facilitate the crossing of challenging vascular lesions, particularly in peripheral artery disease and chronic total occlusions.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular interventions.
What are the FDA-cleared indications?
The device is indicated for crossing difficult vascular lesions, especially in cases of chronic total occlusions.
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.