đź“‹ FDA Reference
ilt support catheter 014 model c114lw1 ilt support catheter advancing mechanism model a11am1
Intra Luminal Therapeutics
Summary: The ILT Support Catheter is a Class 2 medical device used for advancing venous stents. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K012169 ↗
Decision Date
August 30, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ILT Support Catheter received FDA clearance via the 510k pathway on August 30, 2001. It is manufactured by Intra Luminal Therapeutics and classified as a Class 2 device.
What It Is
The ILT Support Catheter is designed to facilitate the placement and support of venous stents. It includes a catheter and an advancing mechanism that helps in precise stent deployment. This device is crucial in procedures requiring vascular access and stent placement, ensuring stability and accuracy during the intervention.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, this catheter is essential for procedures involving venous stenting. It is particularly useful in treating conditions like venous obstructions or stenosis. The device is typically used in hospital settings, catering to adult patients with vascular complications.
Indications for Use
The FDA indicates this device for use in supporting and advancing venous stents. It is suitable for patients with conditions requiring stent placement in veins, such as those with venous blockages or narrowing.
Practical Considerations
The ILT Support Catheter is compatible with 0.014-inch guidewires, a common size in vascular procedures. Clinicians should be familiar with catheter handling and stent deployment techniques to optimize outcomes. Compatibility with other vascular devices should be verified before use.
Related Literature
The linked study investigated the tissue response to Teflon insulin infusion sets in swine, focusing on insertion angle effects. It found that insertion angle influenced tissue inflammation and insulin distribution. Although not directly related to the ILT Support Catheter, it highlights the importance of insertion technique on device performance. Limitations include its focus on insulin sets and animal models, which may not directly translate to catheter use in humans.
Frequently Asked Questions
What is the ILT Support Catheter used for?
It is used for advancing and supporting venous stents during vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in supporting and advancing venous stents, particularly in cases of venous obstruction or stenosis.
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.