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 ?
510(k)
Number ?
K031417 ↗
Decision Date ?
July 11, 2003
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used during percutaneous vascular procedures that require catheter support and guidewire navigation.
- Intended for use in venous interventions, including procedures involving venous stent placement.
- Used with compatible guidewires to help access and treat abnormalities within the vascular system.
Clinical Applications
- Supporting guidewire placement during venous stenting.
- Helping navigate through venous obstructions or difficult vascular anatomy.
- Providing catheter support during percutaneous treatment of central or iliac venous disease.
- Assisting access and device delivery during image-guided venous interventions.
Practical Considerations
- The catheter has a nominal 0.035-inch guidewire-compatible lumen; clinicians should confirm compatibility with the selected guidewire and other devices.
- Available catheter length and configuration should be matched to the access site, target vessel, and patient anatomy.
- Manipulation should be performed under appropriate imaging guidance using standard sterile vascular-access technique to reduce the risk of dissection, perforation, thrombosis, or bleeding.
- MRI safety information is not established in the supplied FDA record. Confirm the current product labeling before exposing the catheter to an MRI environment.
- Use is subject to standard catheter contraindications and precautions, including clinically significant vascular infection, severe bleeding risk, or inability to obtain safe vascular access.
Procedures that use this device
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.