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medtronic 6f taiga guiding catheter
Medtronic Vascular
Summary: The Medtronic 6F Taiga Guiding Catheter is a device used in vascular procedures to facilitate the placement of stents or other devices. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K192296 ↗
Decision Date
September 20, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Medtronic 6F Taiga Guiding Catheter was cleared via the FDA 510(k) pathway on September 20, 2019. Manufactured by Medtronic Vascular, it is classified as a Class 2 device.
What It Is
The Medtronic 6F Taiga Guiding Catheter is a flexible tube designed to navigate through the vascular system to reach the target site. It provides support for the delivery of other devices, such as stents, during interventional procedures. The catheter's design allows for precise control and stability, which is crucial for successful outcomes in vascular interventions.
Clinical Applications
This guiding catheter is commonly used in procedures involving the placement of venous stents, particularly in the treatment of venous obstructions. It is utilized in settings such as catheterization labs by specialists in interventional cardiology and radiology. The device is suitable for adult patients requiring vascular interventions, especially those with complex vascular anatomies.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in guiding other devices to the target site within the vascular system. It is particularly useful for patients needing stent placement in veins.
Practical Considerations
The 6F sizing of the catheter indicates its compatibility with a wide range of vascular devices. Clinicians should ensure compatibility with other procedural tools and consider the catheter's length and flexibility for optimal navigation through the vascular pathways.
Frequently Asked Questions
What is the Medtronic 6F Taiga Guiding Catheter used for?
It is used to guide and support the placement of stents and other devices during vascular interventions.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in guiding other devices to target sites in the vascular system, especially for venous stent placement.
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.