đź“‹ FDA Reference
agilis steerable catheter introducer model 408304
St. Jude Medical, Daig Division
Summary: The Agilis Steerable Catheter Introducer is a medical device used to facilitate the introduction of catheters into the heart. It is primarily used by cardiologists during procedures such as electrophysiology studies and catheter ablations.
FDA Clearance Information
Pathway
510K
Number
K042623 ↗
Decision Date
January 27, 2005
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Agilis Steerable Catheter Introducer, manufactured by St. Jude Medical, was cleared via the FDA 510(k) pathway on January 27, 2005. It is classified as a Class 2 device under product code DYB.
What It Is
The Agilis Steerable Catheter Introducer is a specialized medical device designed to aid in the precise placement of catheters within the heart. It features a steerable tip that allows for enhanced navigation through the vascular system, providing clinicians with greater control during cardiac procedures. This device is particularly useful in complex cardiac interventions where precise catheter positioning is critical.
Clinical Applications
Commonly used in electrophysiology labs, the Agilis Steerable Catheter Introducer is integral to procedures such as catheter ablations and electrophysiological mapping. Cardiologists and electrophysiologists utilize this device to navigate the intricate pathways of the heart, particularly in patients with arrhythmias. It is also used in settings where precise catheter placement is necessary, such as in the treatment of atrial fibrillation.
Indications for Use
The FDA-cleared indications for the Agilis Steerable Catheter Introducer include its use in facilitating the placement of diagnostic and therapeutic catheters in the heart. It is particularly indicated for patients undergoing procedures that require precise catheter navigation and placement.
Practical Considerations
The Agilis Steerable Catheter Introducer is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and is designed for use with standard vascular access techniques. Clinicians should be familiar with its steerable mechanism to optimize its use during procedures.
Frequently Asked Questions
What is the Agilis Steerable Catheter Introducer used for?
It is used to facilitate the introduction and precise placement of catheters in the heart during cardiac procedures.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device during electrophysiology studies and catheter ablations.
What are the FDA-cleared indications?
The device is indicated for facilitating the placement of diagnostic and therapeutic catheters in the heart, especially in procedures requiring precise navigation.
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.