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schneider monorail-gex tm guidewire exchange cath
Schneider Intl.
Summary: The Schneider Monorail-Gex TM Guidewire Exchange Catheter is a medical device used primarily in vascular procedures to facilitate the exchange of guidewires. It is typically used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K902587 ↗
Decision Date
December 3, 1990
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Schneider Monorail-Gex TM Guidewire Exchange Catheter was cleared through the FDA 510(k) pathway on December 3, 1990, by Schneider Intl. It is classified as a Class 2 device under product code DQY.
What It Is
The Schneider Monorail-Gex TM Guidewire Exchange Catheter is designed to assist in the exchange of guidewires during vascular interventions. It operates on a monorail system, allowing for precise control and maneuverability within the vascular system. This device is particularly useful in procedures requiring multiple guidewire exchanges, enhancing procedural efficiency and safety.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly during procedures involving venous stenting. It is suitable for use in hospitals and specialized clinics, where vascular interventions are performed. The device is often used in adult patients undergoing complex vascular procedures that require the exchange of guidewires to navigate through challenging vascular anatomy.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring the exchange of guidewires, particularly in the context of venous stenting. It is suitable for patients undergoing vascular interventions where precise guidewire management is critical.
Practical Considerations
The Schneider Monorail-Gex TM Guidewire Exchange Catheter is typically available in various sizes to accommodate different procedural needs. It is compatible with standard guidewires and is designed for ease of use in complex vascular procedures. Clinicians should ensure compatibility with existing equipment and be familiar with monorail catheter techniques.
Frequently Asked Questions
What is the Schneider Monorail-Gex TM Guidewire Exchange Cath used for?
It is used to facilitate the exchange of guidewires during vascular interventions, particularly in procedures involving venous stenting.
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 procedures requiring guidewire exchanges, particularly in the context of venous stenting.
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.