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ilt safe-cross deflecting catheter model c114nd1
Intra Luminal Therapeutics
Summary: The ilt safe-cross deflecting catheter is a medical device used in vascular procedures, specifically for venous stenting. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K032784 ↗
Decision Date
November 18, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ilt safe-cross deflecting catheter, manufactured by Intra Luminal Therapeutics, was cleared through the FDA 510k pathway on November 18, 2003. It is classified as a Class 2 device under product code DQY.
What It Is
The ilt safe-cross deflecting catheter is a specialized catheter designed to assist in the placement of venous stents. It features a deflecting tip that aids in navigating through complex vascular pathways. This device is particularly useful in procedures requiring precise stent placement in venous systems, enhancing the clinician's ability to manage challenging vascular conditions.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings, particularly for patients requiring venous stenting due to conditions like chronic venous insufficiency or venous obstructions. It is suitable for use in hospital catheterization labs and outpatient vascular centers. The device is beneficial for adult patients with complex venous anatomy that necessitates precise stent placement.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures involving the placement of venous stents. It is particularly useful for patients with venous diseases that require stenting to restore proper blood flow.
Practical Considerations
The ilt safe-cross deflecting catheter is available in various sizes to accommodate different patient anatomies. It is compatible with standard guidewires and stents used in venous interventions. Clinicians should be familiar with catheter manipulation techniques to optimize its deflecting capabilities during procedures.
Frequently Asked Questions
What is ilt safe-cross deflecting catheter used for?
It is used for assisting in the placement of venous stents during vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the placement of venous stents to treat venous diseases.
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.