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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 ?
510(k)
Number ?
K950047 ↗
Decision Date ?
April 5, 1995
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous use in vascular procedures that require guidewire exchange.
- Use as a catheter for vascular access and guidewire manipulation under imaging guidance.
- Use in procedures involving treatment of vascular obstruction or stenosis when guidewire exchange is required.
Clinical Applications
- Exchanging guidewires during venous stent placement.
- Maintaining vascular access while changing guidewires during an endovascular procedure.
- Guidewire exchange during treatment of venous obstruction or stenosis.
- Use in an interventional radiology or vascular surgery procedure performed through percutaneous vascular access.
Practical Considerations
- Confirm compatibility among the catheter, guidewire diameter, introducer sheath, and other devices before use.
- Use fluoroscopic or other appropriate imaging guidance and advance the catheter gently to reduce the risk of vascular injury.
- The record identifies the product as a 0.014/0.018 guidewire exchange catheter; users should verify the specific available size and dimensions in the current labeling or package documentation.
- MRI safety is not established by the information provided in this FDA record. Review the current device labeling before an MRI examination.
- Contraindications, warnings, and precautions should be checked in the current manufacturer instructions; risks may include bleeding, infection, vessel injury, thrombosis, embolization, and device malfunction.
Procedures that use this device
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.