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wingman 14c crossing catheter
Reflow Medical
Summary: The Wingman 14c Crossing Catheter is a medical device used to facilitate the crossing of vascular lesions. It is primarily used by interventional cardiologists and radiologists in procedures involving venous stents.
FDA Clearance Information
Pathway
510K
Number
K170996 ↗
Decision Date
June 9, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Wingman 14c Crossing Catheter was cleared through the FDA 510k pathway on June 9, 2017. Manufactured by Reflow Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Wingman 14c 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 and stenotic segments within blood vessels. This device is particularly useful in peripheral vascular interventions, enhancing the ability to deliver therapeutic devices to the target site.
Clinical Applications
This catheter is commonly used in interventional cardiology and radiology settings, particularly in procedures involving peripheral artery disease (PAD) and chronic total occlusions (CTOs). It is utilized in hospitals and specialized clinics where endovascular procedures are performed. Patients with complex vascular conditions, especially those requiring venous stenting, are typical candidates for procedures involving this device.
Indications for Use
The Wingman 14c Crossing Catheter is indicated for use in patients with vascular lesions that are difficult to cross with standard guidewires. It is particularly beneficial for those with peripheral artery disease or chronic total occlusions, where traditional methods may fail.
Practical Considerations
The Wingman 14c is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewire systems and requires careful manipulation to navigate through complex lesions. Clinicians should be trained in endovascular techniques to maximize the device's effectiveness.
Frequently Asked Questions
What is the Wingman 14c Crossing Catheter used for?
It is used to facilitate the crossing of difficult vascular lesions, particularly in peripheral artery disease and chronic total occlusions.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for crossing vascular lesions in patients with peripheral artery disease or 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.