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vascular solutions twin-pass dual access catheter
Vascular Solutions
Summary: The Vascular Solutions Twin-Pass Dual Access Catheter is a specialized catheter used in vascular procedures to facilitate dual access to a vessel. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K052257 ↗
Decision Date
November 23, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Twin-Pass Dual Access Catheter by Vascular Solutions was cleared via the FDA 510(k) pathway on November 23, 2005. It is a Class 2 medical device under product code DQY.
What It Is
The Twin-Pass Dual Access Catheter is a dual-lumen catheter designed to provide simultaneous access to a vessel through a single entry point. It allows clinicians to perform complex vascular interventions by facilitating the delivery of guidewires and other devices. The catheter's design enables precise navigation and positioning within the vascular system, making it a valuable tool in interventional procedures.
Clinical Applications
This catheter is commonly used in interventional cardiology and radiology for procedures involving the placement of stents or other vascular interventions. It is particularly useful in complex cases where dual access is required, such as in the treatment of chronic total occlusions or bifurcation lesions. The device is typically used in hospital settings by specialists trained in endovascular techniques.
Indications for Use
The FDA-cleared indications for the Twin-Pass Dual Access Catheter include its use in procedures requiring dual access to a vessel, such as the placement of venous stents. It is intended for patients undergoing complex vascular interventions where enhanced access and control are necessary.
Practical Considerations
The Twin-Pass Dual Access Catheter is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard guidewires and can be used in conjunction with other interventional devices. Clinicians should be familiar with dual-lumen catheter techniques to optimize its use.
Frequently Asked Questions
What is the Vascular Solutions Twin-Pass Dual Access Catheter used for?
It is used to provide dual access to a vessel during complex vascular interventions, such as stent placements.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring dual access to a vessel, such as venous stent placements.
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.