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iti intramax guide catheter 91 78 and 65
Intratherapeutics
Summary: The Intramax Guide Catheter is a medical device used in vascular procedures to facilitate the placement of stents. It is primarily utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K981191 ↗
Decision Date
April 7, 1999
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Intramax Guide Catheter, manufactured by Intratherapeutics, was cleared by the FDA via the 510k pathway on April 7, 1999. It is classified as a Class 2 device under product code DQY.
What It Is
The Intramax Guide Catheter is a flexible tube designed to provide a pathway for other instruments, such as stents, into the vascular system. It is used to navigate through blood vessels and is essential in procedures requiring precise placement of devices within the venous system. Its design allows for easy maneuverability and stability during interventional procedures.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures involving the placement of venous stents. It is particularly useful in settings such as hospitals and specialized clinics where vascular interventions are performed. Patients with conditions such as venous obstructions or requiring vascular access for treatment benefit from its use.
Indications for Use
The FDA-cleared indications for the Intramax Guide Catheter include its use in facilitating the placement of venous stents. It is intended for patients who require vascular interventions to address issues such as blockages or narrowed veins.
Practical Considerations
The Intramax Guide Catheter comes in various sizes, typically 91, 78, and 65 cm, to accommodate different patient anatomies and procedural needs. It is compatible with standard vascular access techniques and should be selected based on the specific requirements of the procedure and patient anatomy.
Frequently Asked Questions
What is the Intramax Guide Catheter used for?
It is used to facilitate the placement of venous stents during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of venous stents in patients requiring vascular interventions.
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.