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Wildcat 7f Guidewire Support Catheter
Summary: The Wildcat 7F Guidewire Support Catheter by Avinger is used in vascular procedures to assist in crossing lesions. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K083313 ↗
Decision Date ?
February 2, 2009
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Wildcat 7F Guidewire Support Catheter was cleared through the FDA 510(k) pathway on February 2, 2009. It is manufactured by Avinger and is classified as a Class 2 device.
What It Is
The Wildcat 7F Guidewire Support Catheter is a medical device designed to facilitate the crossing of vascular lesions during endovascular procedures. It provides support and stability to guidewires, enabling precise navigation through complex vascular pathways. The device is particularly useful in procedures requiring enhanced control and maneuverability.
FDA-Cleared Indications
- Facilitation of guidewire crossing through lesions in the peripheral vasculature.
- Use during endovascular treatment of peripheral vascular lesions that obstruct or limit guidewire passage.
Clinical Applications
- Supporting guidewire navigation across peripheral arterial stenoses.
- Supporting guidewire crossing of peripheral arterial occlusions.
- Facilitating endovascular access across difficult peripheral vascular lesions.
- Use in catheter-based peripheral vascular interventions when additional guidewire support is needed.
Practical Considerations
- The device is a 7 French guidewire support catheter; the access sheath, guidewire and other components must be compatible with its size and intended use.
- Use requires fluoroscopic or other appropriate intravascular imaging guidance by clinicians trained in endovascular procedures.
- Handling should follow the current manufacturer instructions for use, including preparation, advancement, withdrawal and precautions against vessel injury.
- The FDA record and product code do not establish that the catheter is MRI safe or MRI conditional; MRI compatibility should be confirmed in the current labeling.
- Potential complications are related to catheterization and lesion crossing and may include vascular injury, bleeding, thrombosis, embolization, infection or vessel perforation.
Procedures that use this device
Frequently Asked Questions
What is the Wildcat 7F Guidewire Support Catheter used for?
It is used to assist in crossing vascular lesions during endovascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the crossing of lesions in the peripheral vasculature.
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.