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itc introducer catheter
Interventional Therapeutics
Summary: The ITC Introducer Catheter is a medical device used primarily in interventional radiology and cardiology for the introduction of embolization coils. It is utilized by healthcare professionals in procedures requiring vascular access.
FDA Clearance Information
Pathway
510K
Number
K900756 ↗
Decision Date
August 8, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The ITC Introducer Catheter was cleared through the FDA 510(k) pathway on August 8, 1990, by Interventional Therapeutics. It is classified as a Class 2 device under product code DYB.
What It Is
The ITC Introducer Catheter is a specialized catheter designed to facilitate the insertion of embolization coils into the vascular system. It is typically used in minimally invasive procedures to achieve vascular occlusion. The device is engineered to provide a stable and secure pathway for the delivery of therapeutic agents or devices within the vasculature.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures such as embolization of vascular malformations or aneurysms. It is particularly useful in treating conditions that require precise placement of embolic materials to block blood flow to specific areas. The catheter is often employed in hospital settings, catering to adult and pediatric patient populations requiring vascular interventions.
Indications for Use
The ITC Introducer Catheter is indicated for use in procedures that require the introduction of embolization coils to occlude blood vessels. It is suitable for patients with conditions such as aneurysms or arteriovenous malformations where targeted vascular occlusion is necessary.
Practical Considerations
The catheter is available in various sizes to accommodate different vascular anatomies and procedural requirements. It is compatible with standard embolization coils and requires careful handling to ensure precise placement. Clinicians should be familiar with the specific technique for its insertion and use.
Frequently Asked Questions
What is the ITC Introducer Catheter used for?
The ITC Introducer Catheter is used for the introduction of embolization coils into the vascular system to achieve targeted occlusion.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in procedures requiring vascular access and embolization.
What are the FDA-cleared indications?
The device is indicated for the introduction of embolization coils to occlude blood vessels in conditions like aneurysms and arteriovenous malformations.
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.