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vascular solutions twin-pass dual access catheter and skyway support catheter
Vascular Solutions
Summary: The Twin-Pass Dual Access Catheter and Skyway Support Catheter are used in vascular interventions, primarily by interventional cardiologists and radiologists, to facilitate access and support during procedures involving venous stents.
FDA Clearance Information
Pathway
510K
Number
K060327 ↗
Decision Date
April 12, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Twin-Pass Dual Access Catheter and Skyway Support Catheter, manufactured by Vascular Solutions, received FDA clearance via the 510(k) pathway on April 12, 2006. They are classified as Class 2 devices under product code DQY.
What It Is
The Twin-Pass Dual Access Catheter is designed to provide dual access for guidewire exchange and delivery of therapeutic agents during vascular procedures. The Skyway Support Catheter offers additional support and stability for guidewires in tortuous or complex vascular anatomy. These devices are integral in facilitating precise interventions in challenging vascular environments.
Clinical Applications
These catheters are commonly used in interventional cardiology and radiology settings, particularly during procedures involving the placement of venous stents. They are essential in cases requiring dual-lumen access for guidewire manipulation and delivery of contrast or therapeutic agents. Patients with complex vascular conditions or those undergoing revascularization procedures often benefit from their use.
Indications for Use
The FDA-cleared indications for these catheters involve their use in procedures requiring dual-lumen access for guidewire exchange and support in vascular interventions. They are particularly useful in patients needing precise stent placement in venous systems.
Practical Considerations
These catheters are available in various sizes to accommodate different patient anatomies and procedural needs. They are compatible with standard guidewires and should be used with care in tortuous vessels to avoid vessel trauma. Familiarity with catheter manipulation techniques is essential for optimal use.
Frequently Asked Questions
What is the Twin-Pass and Skyway Catheter used for?
These catheters are used for dual-lumen access and support during vascular interventions, particularly in procedures involving venous stents.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use these catheters in vascular procedures.
What are the FDA-cleared indications?
The devices are indicated for use in procedures requiring dual-lumen access for guidewire exchange and support 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.