📋 FDA Reference
Wingman 14 Wingman 14c Wingman 18 Wingman 35
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 ?
510(k)
Number ?
K193596 ↗
Decision Date ?
February 20, 2020
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used to provide support and facilitate the placement of guidewires during percutaneous vascular procedures.
- Used to assist in crossing peripheral vascular lesions that are difficult to traverse with a guidewire alone.
- Intended for use in the peripheral vasculature by appropriately trained clinicians.
Clinical Applications
- Crossing difficult peripheral arterial lesions during endovascular treatment.
- Supporting guidewire placement through complex or occluded peripheral vessels.
- Assisting lesion crossing during peripheral angioplasty and other catheter-based vascular interventions.
- Providing additional catheter support when standard guidewire access is insufficient.
Practical Considerations
- The series includes Wingman 14, Wingman 14C, Wingman 18, and Wingman 35; the appropriate model depends on vessel size, access system, lesion characteristics, and required support.
- Confirm compatibility with the selected guidewire, sheath, guide catheter, contrast agent, and other equipment before use.
- Use fluoroscopic or other appropriate intravascular imaging guidance and follow the current manufacturer instructions for preparation, advancement, and tip deployment.
- As with other intravascular catheters, risks include vessel injury, perforation, dissection, thrombosis, embolization, bleeding, infection, and contrast-related complications.
- MRI safety depends on the specific device configuration and labeling. Confirm the current manufacturer MRI information before an MRI examination; do not assume the device is MRI safe or conditional.
Procedures that use this device
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.