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avinger wildcat 6f guidewire support catheter and juicebox
Avinger
Summary: The Avinger Wildcat 6F Guidewire Support Catheter and Juicebox is a device used in vascular interventions to support guidewire navigation and facilitate catheter placement. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K111704 ↗
Decision Date
September 9, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Avinger Wildcat 6F Guidewire Support Catheter and Juicebox was cleared through the FDA 510(k) pathway on September 9, 2011. It is manufactured by Avinger and classified as a Class 2 medical device.
What It Is
The Avinger Wildcat 6F Guidewire Support Catheter and Juicebox is a specialized catheter system designed to aid in the navigation and placement of guidewires during vascular procedures. It provides enhanced support and stability to guidewires, allowing for precise catheter placement in challenging vascular anatomy. The Juicebox component may refer to an accessory that powers or enhances the catheter's functionality.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for procedures involving venous stents and other vascular interventions. It is particularly useful in cases where vascular access is difficult or when navigating tortuous or occluded vessels. The device is suitable for adult patients requiring vascular interventions, including those with peripheral artery disease.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in vascular procedures that require guidewire support, particularly in the placement of venous stents. It is designed to assist clinicians in navigating complex vascular pathways.
Practical Considerations
The Wildcat 6F is typically compatible with standard guidewires and catheters used in vascular procedures. Clinicians should be familiar with the device's operation and ensure compatibility with existing equipment. Proper technique is essential for optimal performance and patient safety.
Frequently Asked Questions
What is the Avinger Wildcat 6F Guidewire Support Catheter and Juicebox used for?
It is used to support guidewire navigation and facilitate catheter placement during vascular interventions, particularly in challenging vascular anatomy.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in vascular procedures requiring guidewire support, especially for the placement of 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.