đź“‹ FDA Reference
modification to braided guiding introducer
Thomas Medical Products
Summary: The braided guiding introducer by Thomas Medical Products is a Class II medical device used in vascular procedures, primarily by interventional radiologists and cardiologists. It facilitates the introduction of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K013202 ↗
Decision Date
October 23, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The braided guiding introducer was cleared through the FDA 510(k) pathway on October 23, 2001. Manufactured by Thomas Medical Products, it is classified as a Class II device under product code DYB.
What It Is
The braided guiding introducer is a medical device designed to assist in the insertion of catheters and other instruments into the vascular system. It features a braided design that provides flexibility and strength, allowing for precise navigation through blood vessels. This device is typically used in minimally invasive procedures, where its design helps reduce trauma to the vessel walls.
Clinical Applications
Commonly used in interventional radiology and cardiology, the braided guiding introducer is essential in procedures such as embolization, angioplasty, and stent placement. It is particularly useful in settings where access to the vascular system is required, such as hospitals and specialized outpatient centers. The device is suitable for a wide range of patient populations, including those undergoing treatment for vascular diseases or conditions requiring catheter-based interventions.
Indications for Use
The FDA-cleared indications for this device involve its use in procedures requiring vascular access, such as the placement of embolization coils. It is designed for patients needing interventions that involve navigating through the vascular system.
Practical Considerations
The braided guiding introducer is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of catheters and devices, making it versatile for multiple procedures. Clinicians should be familiar with the specific technique for insertion and navigation to optimize outcomes and minimize complications.
Frequently Asked Questions
What is the braided guiding introducer used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system during procedures like embolization and angioplasty.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, such as the placement of embolization coils.
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.