đź“‹ FDA Reference
ilt safe cross 0 035 support catheter model c135sn1
Intra Luminal Therapeutics
Summary: The ilt safe cross 0 035 support catheter is a device used in vascular procedures, primarily by interventional radiologists and cardiologists. It aids in navigating and supporting guidewires during venous stenting procedures.
FDA Clearance Information
Pathway
510K
Number
K031417 ↗
Decision Date
July 11, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ilt safe cross 0 035 support catheter was cleared via the FDA 510k pathway on July 11, 2003. Manufactured by Intra Luminal Therapeutics, it is classified as a Class 2 medical device.
What It Is
The ilt safe cross 0 035 support catheter is a specialized catheter designed to facilitate the placement and support of guidewires during vascular interventions. It features a 0.035-inch lumen that provides stability and support, allowing for precise navigation through the vascular system. This device is particularly useful in complex procedures requiring enhanced control and support.
Clinical Applications
This support catheter is commonly used in interventional radiology and cardiology settings, particularly in procedures involving venous stenting. It is employed in hospitals and specialized clinics where vascular interventions are performed. The device is suitable for use in adult patients requiring venous access for stent placement, especially in cases of venous obstructions or anomalies.
Indications for Use
The FDA-cleared indications for this device involve its use in procedures requiring venous stenting. It is intended for patients with conditions such as venous obstructions where stenting is necessary to restore or maintain adequate blood flow.
Practical Considerations
The ilt safe cross 0 035 support catheter is compatible with standard guidewires and is available in various lengths to accommodate different anatomical needs. Clinicians should ensure proper technique in catheter manipulation to prevent vascular injury and optimize procedural outcomes.
Frequently Asked Questions
What is ilt safe cross 0 035 support catheter used for?
It is used to support and guide wires during venous stenting procedures, aiding in the navigation and placement of stents.
What specialties typically use this device?
Interventional radiologists and cardiologists primarily use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures to address venous obstructions and ensure proper blood flow.
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.