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twin-pass otw catheter model 5201
Vascular Solutions
Summary: The Twin-Pass OTW Catheter is a dual-lumen catheter used in interventional cardiology and radiology for accessing and treating complex vascular lesions. It is primarily used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K072618 ↗
Decision Date
November 21, 2007
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Twin-Pass OTW Catheter, manufactured by Vascular Solutions, received FDA clearance through the 510(k) pathway on November 21, 2007. It is classified as a Class II device under product code DQY.
What It Is
The Twin-Pass OTW Catheter is a dual-lumen catheter designed for use in percutaneous procedures to facilitate the delivery of guidewires and therapeutic agents to specific vascular sites. Its over-the-wire design allows for precise navigation through complex vascular anatomy, making it a valuable tool in interventions requiring access to difficult-to-reach lesions.
Clinical Applications
This catheter is commonly used in procedures involving the placement of venous stents, particularly in patients with peripheral artery disease or complex coronary artery disease. It is utilized in both hospital and outpatient settings, primarily by interventional cardiologists and radiologists. The device is suitable for adult patients requiring targeted vascular interventions.
Indications for Use
The FDA indications suggest that the Twin-Pass OTW Catheter is intended for use in patients who require precise delivery of guidewires or therapeutic agents to vascular sites. This includes patients with complex vascular lesions that are challenging to access with standard catheters.
Practical Considerations
The Twin-Pass OTW Catheter is available in various sizes to accommodate different vessel diameters and lesion locations. It is compatible with standard guidewires and can be used in conjunction with other interventional devices. Clinicians should be familiar with catheter manipulation techniques to optimize its use in complex anatomy.
Frequently Asked Questions
What is the Twin-Pass OTW Catheter used for?
It is used for delivering guidewires and therapeutic agents to specific vascular sites, particularly in complex vascular interventions.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in accessing and treating complex vascular lesions, facilitating the delivery of guidewires and therapeutic agents.
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.