đź“‹ FDA Reference
gopher 2f support catheter model 5600 and gopher 3f support catheter model 5610
Vascular Solutions
Summary: The Gopher 2f and 3f support catheters are used in interventional procedures to facilitate the placement of guidewires and other devices. They are primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K070372 ↗
Decision Date
June 1, 2007
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Gopher 2f and 3f support catheters, manufactured by Vascular Solutions, were cleared via the FDA 510k pathway on June 1, 2007. They are classified as Class 2 devices under product code DQY.
What It Is
The Gopher 2f and 3f support catheters are specialized medical devices designed to aid in the navigation and support of guidewires during vascular interventions. These catheters are flexible and can be maneuvered through the vascular system to reach target sites, providing stability and support for subsequent procedures. They are essential tools in complex vascular interventions, allowing clinicians to access difficult-to-reach areas.
Clinical Applications
These support catheters are commonly used in procedures involving the placement of venous stents, particularly in cases where access to the venous system is challenging. They are frequently utilized in interventional radiology and cardiology settings, where precision and support are critical. The devices are suitable for a range of patient populations, including those with peripheral vascular disease or other conditions requiring vascular intervention.
Indications for Use
The Gopher support catheters are indicated for use in facilitating the placement and support of guidewires and other devices during vascular interventions. They are particularly useful in procedures involving venous stenting, where they help navigate through complex vascular anatomy.
Practical Considerations
The Gopher catheters come in 2f and 3f sizes, offering flexibility for different procedural needs. They are compatible with a variety of guidewires and can be used in conjunction with other interventional devices. Clinicians should be familiar with catheter manipulation techniques to optimize their use in complex vascular pathways.
Frequently Asked Questions
What is the Gopher support catheter used for?
The Gopher support catheter is used to facilitate the placement of guidewires and other devices during vascular interventions, particularly in venous stenting procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use the Gopher support catheters in their procedures.
What are the FDA-cleared indications?
The Gopher support catheters are cleared for use in facilitating the placement and support of guidewires and other devices during vascular interventions, such as venous stenting.
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.