đź“‹ FDA Reference
wingman 14 wingman 14c wingman 18 wingman 35
Reflow Medical
Summary: The Wingman catheters by Reflow Medical are used in vascular procedures to facilitate the crossing of lesions. They are primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K193596 ↗
Decision Date
February 20, 2020
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Wingman catheters received FDA clearance through the 510(k) pathway on February 20, 2020. Manufactured by Reflow Medical, they are classified as Class 2 devices under product code DQY.
What It Is
The Wingman catheters are a series of support catheters designed to assist in crossing vascular lesions. They feature a unique extendable tip that aids in navigating through difficult or occluded vessels. These devices are particularly useful in peripheral vascular interventions where enhanced guidewire support is needed.
Clinical Applications
Wingman catheters are commonly used in endovascular procedures to treat peripheral artery disease (PAD) and other vascular conditions. They are utilized in both hospital and outpatient settings by specialists in interventional cardiology and radiology. The devices are suitable for adult patients with complex vascular anatomies requiring precise lesion crossing.
Indications for Use
The Wingman catheters are indicated for use in patients with vascular lesions that are difficult to cross with standard guidewires. They are designed to facilitate the crossing of chronic total occlusions (CTOs) and other challenging vascular blockages.
Practical Considerations
The Wingman series includes different sizes (14, 14c, 18, 35) to accommodate various vessel diameters and lesion types. Clinicians should consider vessel size and lesion characteristics when selecting the appropriate catheter. Compatibility with existing guidewires and other interventional tools should also be assessed.
Frequently Asked Questions
What is Wingman used for?
Wingman catheters are used to facilitate the crossing of difficult vascular lesions, particularly in peripheral artery disease.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use Wingman catheters in vascular procedures.
What are the FDA-cleared indications?
The Wingman catheters are indicated for crossing vascular lesions that are challenging to navigate with standard guidewires.
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.