📋 FDA Reference
Wingman 14c Crossing Catheter
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 ?
510(k)
Number ?
K170996 ↗
Decision Date ?
June 9, 2017
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Facilitates crossing of peripheral vascular lesions that are difficult to traverse with standard guidewire techniques.
- Used to support endovascular treatment of stenotic or occluded vascular segments.
- Intended for percutaneous intravascular use under imaging guidance by trained clinicians.
Clinical Applications
- Crossing complex peripheral arterial stenoses during endovascular intervention.
- Crossing chronic total occlusions or other occluded segments when standard crossing methods are unsuccessful.
- Creating a pathway for delivery of angioplasty balloons, stents, or other therapeutic devices after the lesion has been crossed.
- Supporting catheter-based treatment of peripheral vascular disease in appropriately selected patients.
Practical Considerations
- The catheter should be used by clinicians trained in percutaneous endovascular procedures and manipulated under fluoroscopic imaging.
- The available catheter size and length must match the target vessel, access route, guidewire system, and planned treatment device.
- Compatibility with the guidewire, introducer sheath, and other equipment should be confirmed in the current manufacturer instructions for use.
- The device is not a treatment by itself; additional therapy such as angioplasty, stenting, thrombectomy, medication, or surgery may be required.
- MRI safety and conditions are device-specific and should be confirmed in the current labeling before an MRI examination.
Procedures that use this device
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.