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trailblazer angled support catheter
Medtronic Vascular, Inc.(Formerly Ev3 Inc.)
Summary: The Trailblazer Angled Support Catheter is a medical device used primarily in vascular procedures to facilitate the placement of guidewires and other devices. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K162384 ↗
Decision Date
September 22, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Trailblazer Angled Support Catheter was cleared through the FDA 510(k) pathway on September 22, 2016. It is manufactured by Medtronic Vascular, Inc. and is classified as a Class 2 medical device.
What It Is
The Trailblazer Angled Support Catheter is designed to provide support and facilitate the navigation of guidewires and other interventional devices through the vascular system. Its angled tip aids in accessing difficult-to-reach areas, making it a valuable tool in complex vascular procedures. The catheter is constructed to offer flexibility and support, enhancing the precision of device placement.
Clinical Applications
This catheter is commonly used in endovascular procedures, particularly in the placement of venous stents. It is utilized in settings such as interventional radiology suites and vascular surgery centers. The device is suitable for patients requiring vascular interventions, including those with peripheral artery disease or venous obstructions.
Indications for Use
The FDA indications suggest that this device is intended for use in vascular procedures to aid in the placement of guidewires and other devices. It is particularly useful in patients with complex vascular anatomy or those undergoing stent placement.
Practical Considerations
The Trailblazer Angled Support Catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and can be used in conjunction with other interventional tools. Clinicians should be familiar with its handling and navigation techniques to maximize its effectiveness.
Frequently Asked Questions
What is the Trailblazer Angled Support Catheter used for?
It is used to facilitate the placement of guidewires and other interventional devices in vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in vascular procedures to aid in the placement of guidewires and other devices, particularly in complex vascular anatomy.
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.