đź“‹ FDA Reference
itc catheters w hydromer
Interventional Therapeutics
Summary: The ITC Catheters with Hydromer are specialized devices used primarily in venous stenting procedures. They are utilized by interventional radiologists and vascular surgeons to facilitate the placement of stents in veins.
FDA Clearance Information
Pathway
510K
Number
K922609 ↗
Decision Date
April 30, 1993
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ITC Catheters with Hydromer were cleared through the FDA 510(k) pathway on April 30, 1993. Manufactured by Interventional Therapeutics, this device is classified as Class 2 under product code DQY.
What It Is
The ITC Catheters with Hydromer are designed for use in venous stenting procedures. They feature a hydrophilic coating, known as Hydromer, which reduces friction and facilitates smoother navigation through the vascular system. This is particularly beneficial in procedures requiring precise placement and maneuvering within the venous system.
Clinical Applications
These catheters are commonly used in interventional radiology and vascular surgery settings. They are employed in procedures involving venous stenting, particularly in patients with conditions such as deep vein thrombosis or venous insufficiency. The device is suitable for use in hospital catheterization labs and outpatient surgical centers.
Indications for Use
The FDA-cleared indications for the ITC Catheters with Hydromer involve their use in venous stenting procedures. They are intended for patients requiring stent placement in veins, often due to conditions like blocked or narrowed veins.
Practical Considerations
The catheters are available in various sizes to accommodate different patient anatomies and procedural requirements. They are compatible with standard stenting equipment and require careful handling to maintain the integrity of the hydrophilic coating during insertion and navigation.
Frequently Asked Questions
What is ITC Catheters with Hydromer used for?
They are used for facilitating venous stenting procedures, helping in the placement of stents in veins.
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 venous stenting procedures, particularly for patients with conditions requiring stent placement in veins.
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.