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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 lesions in the peripheral vasculature. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K190393 ↗
Decision Date
May 9, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Wingman 14c Crossing Catheter by Reflow Medical was cleared through the FDA 510(k) pathway on May 9, 2019. It is classified as a Class 2 device under product code DQY.
What It Is
The Wingman 14c Crossing Catheter is designed to assist in the crossing of complex lesions in the peripheral vasculature. It features a unique tip that can be manipulated to navigate through challenging blockages. This catheter is particularly useful in procedures requiring precise navigation and lesion crossing, providing enhanced control for clinicians.
Clinical Applications
This device is commonly used in endovascular procedures to treat peripheral artery disease (PAD), especially in cases where standard guidewires cannot easily cross a lesion. It is typically utilized in hospital settings by interventional radiologists and vascular surgeons. The catheter is suitable for adult patients with complex vascular lesions requiring intervention.
Indications for Use
The Wingman 14c Crossing Catheter is indicated for use in patients with peripheral vascular disease who have lesions that are difficult to cross with standard guidewires. It is designed to assist in navigating through blockages in the peripheral arteries.
Practical Considerations
The Wingman 14c Crossing Catheter is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewire systems and requires careful manipulation to optimize its crossing capabilities. Clinicians should be familiar with its unique tip design to maximize effectiveness.
Frequently Asked Questions
What is the Wingman 14c Crossing Catheter used for?
It is used to facilitate the crossing of difficult lesions in the peripheral vasculature, particularly in patients with peripheral artery disease.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device during endovascular procedures.
What are the FDA-cleared indications?
The catheter is indicated for crossing lesions in the peripheral vasculature, particularly in cases where standard guidewires are insufficient.
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.