đź“‹ FDA Reference
schneider gex tm 014 018 guidewire exchange catheter
Isomedix Operations
Summary: The Schneider GEX TM 014 018 is a guidewire exchange catheter used in vascular procedures, primarily by interventional radiologists and vascular surgeons. It facilitates the exchange of guidewires during venous stenting procedures.
FDA Clearance Information
Pathway 510K
Number K950047 ↗
Decision Date April 5, 1995
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Schneider GEX TM 014 018 Guidewire Exchange Catheter was cleared through the FDA 510(k) pathway on April 5, 1995. Manufactured by Isomedix Operations, it is classified as a Class 2 device under product code DQY.
What It Is
The Schneider GEX TM 014 018 Guidewire Exchange Catheter is a medical device designed to assist in the exchange of guidewires during vascular interventions. It is typically used in procedures involving the placement of venous stents, where precise guidewire manipulation is crucial. The catheter is engineered to provide a smooth transition and minimize trauma to the vessel walls during guidewire exchanges.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly in procedures involving venous stenting. It is suitable for use in patients requiring vascular access for stent placement, often in cases of venous obstruction or stenosis. The catheter is used in hospital settings, primarily in catheterization labs or operating rooms.
Indications for Use
The FDA-cleared indications for this device involve its use in procedures requiring the exchange of guidewires, particularly in the context of venous stenting. It is intended for patients with conditions that necessitate the placement of stents in the venous system.
Practical Considerations
The Schneider GEX TM 014 018 Guidewire Exchange Catheter is compatible with standard guidewires and is available in typical sizes for vascular procedures. Clinicians should ensure compatibility with the guidewires and stents being used. Proper technique is essential to minimize vessel trauma during exchanges.
Frequently Asked Questions
What is the Schneider GEX TM 014 018 Guidewire Exchange Catheter used for?
It is used to facilitate the exchange of guidewires during vascular procedures, particularly in venous stenting.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring guidewire exchanges, especially 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.