đź“‹ FDA Reference
vascular solutions skyway support catheter
Vascular Solutions
Summary: The Vascular Solutions Skyway Support Catheter is a medical device used primarily in vascular interventions to facilitate the placement of guidewires and other devices. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K052258 ↗
Decision Date
December 13, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Skyway Support Catheter by Vascular Solutions was cleared through the FDA 510(k) pathway on December 13, 2005. It is a Class 2 device under product code DQY.
What It Is
The Vascular Solutions Skyway Support Catheter is a specialized catheter designed to provide support and facilitate the placement of guidewires and other interventional devices within the vascular system. It features a flexible design that allows for navigation through tortuous vascular anatomy. This catheter is particularly useful in procedures requiring precise guidewire placement and stability.
Clinical Applications
This catheter is commonly used in endovascular procedures, such as angioplasty or stenting, where it assists in the navigation and placement of guidewires and stents. Interventional radiologists and cardiologists frequently use it in hospital settings, particularly in catheterization labs. It is suitable for a wide range of patients requiring vascular interventions, including those with complex vascular anatomies.
Indications for Use
The FDA indications suggest that the Skyway Support Catheter is intended for use in facilitating the placement of guidewires and other devices during vascular interventions. It is particularly useful in patients undergoing procedures to treat vascular obstructions or stenosis.
Practical Considerations
The Skyway Support Catheter is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard guidewires and interventional devices. Clinicians should be familiar with the catheter's flexibility and torque response to optimize its use during procedures.
Frequently Asked Questions
What is the Vascular Solutions Skyway Support Catheter used for?
It is used to facilitate the placement of guidewires and other devices during vascular interventions.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the placement of guidewires and other devices during vascular interventions.
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.