đź“‹ FDA Reference
modification to braided guiding introducer system
Thomas Medical Products
Summary: The braided guiding introducer system by Thomas Medical Products is a device used to facilitate the insertion of catheters and other devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K040713 ↗
Decision Date
June 1, 2004
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The braided guiding introducer system was cleared through the FDA 510k pathway on June 1, 2004. Manufactured by Thomas Medical Products, it is classified as a Class 2 device under product code DYB.
What It Is
This device is a modification to a braided guiding introducer system, designed to assist in the placement of catheters and other interventional devices into the vascular system. Its braided design provides flexibility and strength, allowing for easier navigation through blood vessels. The introducer system typically includes a sheath and dilator, which help in creating a pathway for other instruments.
Clinical Applications
Commonly used in procedures involving embolization coils, this device is essential in interventional radiology and cardiology. It is utilized in settings such as hospitals and specialized clinics, often in procedures requiring precise catheter placement in patients with vascular conditions. The device is suitable for adult patients undergoing minimally invasive procedures.
Indications for Use
The FDA indications suggest that this device is intended for use in facilitating the introduction of catheters and other devices into the vascular system. It is particularly useful in patients requiring embolization procedures to manage vascular abnormalities.
Practical Considerations
Clinicians should consider the typical sizing of the introducer system to ensure compatibility with the catheters and devices being used. The braided design enhances maneuverability, but care should be taken to avoid excessive force during insertion. Familiarity with the device's handling characteristics can improve procedural efficiency.
Frequently Asked Questions
What is the braided guiding introducer system used for?
It is used to facilitate the insertion of catheters and other devices into the vascular system, particularly in procedures involving embolization coils.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters and other devices into the vascular system, especially in embolization procedures.
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.