📋 FDA Reference
Twin-Pass OTW Catheter Model 5201
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 ?
510(k)
Number ?
K072618 ↗
Decision Date ?
November 21, 2007
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter use to access vascular sites during interventional procedures.
- Facilitation of guidewire placement or exchange at a selected vascular site.
- Delivery of therapeutic agents to a selected vascular site when used with compatible interventional equipment.
Clinical Applications
- Selective vascular access during percutaneous endovascular procedures.
- Guidewire delivery or exchange in difficult-to-access vascular anatomy.
- Catheter-directed delivery of therapeutic agents to a selected vascular site.
- Support of complex endovascular procedures requiring dual-lumen, over-the-wire catheter access.
Practical Considerations
- The catheter is dual-lumen and over-the-wire; clinicians should confirm the required guidewire size and compatibility before use.
- Available sizes and working lengths should be matched to the target vessel, access route, and lesion location.
- Use requires fluoroscopic or other appropriate imaging guidance and careful catheter manipulation to reduce the risk of vascular injury.
- MRI safety depends on the specific device labeling and the presence of any retained or associated components; verify the current manufacturer instructions before MRI.
- Contraindications, warnings, and use limitations should be checked in the current instructions for use, including incompatibility with selected guidewires, agents, or access systems.
Procedures that use this device
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.