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wingman extendable tip support catheter
Reflow Medical
Summary: The Wingman Extendable Tip Support Catheter is a medical device used in vascular procedures to navigate through difficult lesions. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K132420 ↗
Decision Date
September 19, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Wingman Extendable Tip Support Catheter was cleared through the FDA 510(k) pathway on September 19, 2013. It is manufactured by Reflow Medical and 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 provide support and facilitate the crossing of challenging vascular lesions. It features an extendable tip that aids in navigating through tortuous or occluded vessels. This device is particularly useful in procedures where enhanced support and precise navigation are required.
Clinical Applications
This catheter is commonly used in interventional cardiology and radiology for procedures involving the placement of venous stents or navigating through complex vascular pathways. It is suitable for use in hospital settings, particularly in catheterization labs, and is often employed in patients with peripheral artery disease or other vascular conditions requiring stenting.
Indications for Use
The FDA indications suggest that this device is intended for use in patients who require support during vascular procedures, particularly those involving difficult-to-navigate lesions. It is designed to assist in the placement of stents in venous pathways.
Practical Considerations
The Wingman catheter is available in various sizes to accommodate different vessel diameters and is compatible with standard guidewires and other interventional tools. 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 provide support and facilitate navigation through difficult vascular lesions during interventional 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 use in providing support during vascular procedures, particularly for navigating challenging lesions and placing venous stents.
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.