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intramax iti guide catheter
Intratherapeutics
Summary: The Intramax ITI Guide Catheter is a medical device used in vascular procedures to guide other instruments into the venous system. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K992622 ↗
Decision Date
September 29, 1999
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Intramax ITI Guide Catheter was cleared through the FDA 510k pathway on September 29, 1999, by Intratherapeutics. It is a Class 2 device under product code DQY.
What It Is
The Intramax ITI Guide Catheter is a flexible tube designed to facilitate the introduction of therapeutic devices into the venous system. It is used to navigate through blood vessels, providing a pathway for other instruments or stents. The catheter's design allows for precise control and positioning, which is crucial in complex vascular procedures.
Clinical Applications
This guide catheter is commonly used in interventional cardiology and radiology. It is employed in procedures such as venous stenting, where precise placement of stents is required. The device is suitable for use in hospital settings, particularly in catheterization labs, and is used on patients requiring vascular interventions, including those with venous obstructions or anomalies.
Indications for Use
The FDA indications for the Intramax ITI Guide Catheter include its use in facilitating the placement of stents within the venous system. It is intended for patients who need vascular intervention due to conditions like venous stenosis or blockages.
Practical Considerations
The Intramax ITI Guide Catheter comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard vascular access techniques and should be used with appropriate imaging guidance to ensure accurate placement.
Frequently Asked Questions
What is the Intramax ITI Guide Catheter used for?
It is used to guide other medical instruments into the venous system during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of stents within the venous system.
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.